Singapore HSA registration DE0014424
Integra™ Omni-Tract® Urologic Surgery Retractor Systems
Singapore·CLASS B·Integra LifeSciences Corporation·Registered December 04, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
- HSA Product Code
- HSAMDB00109
- HS Code
- 90189090
Registration information
- Registration Number
- DE0014424
- Registration Date
- December 04, 2013
- Retention Due Date
- December 03, 2025
Product description
An assembly of devices used to create a self-locking mechanism to temporarily part tissue (e.g., hold the edges of a wound open), or other anatomical structures, to expose internal tissues or organs for access during surgery. The assembly may be anchored to the operating room table and may include devices such as horizontal bars, rings, ratchet mechanisms, fibreoptic lights, various attachment devices, and a variety of retractor blades. The component parts are typically made of metal and are reusable after sterilization.
Product Owner
- Short Name
- Integra LifeSciences
- Address
- 311 Enterprise Drive, Plainsboro, NJ 08536, UNITED STATES
Registrant
- Address
- 3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
- Address
- 3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model information
- Model Name(s)
- Articulating Blade Holder Standard WISHBONE Frame Arm Small WISHBONE Arm OMNI-FLEX SUPPORT ARM Hinged Extension Arm, 19" (48.3cm) Mayo Blade, 2.75" X 2" (7cm X 5cm), ABH Style Splanchnic Blade, 2" X 8" (5cm X 20.3cm), ABH Style St. Mark's Blade, 2.5" X 7" (6.4cm X 17.8cm), ABH Style Renal Vein Retractor, 1" x 6" (2.5cm x 15.2cm) Renal Vein Retractor, 1" x 4-1/2" (2.5cm x 11.4cm) Renal Vein Swivel Blade, 1" x 4-1/2" (2.5cm x 11.4cm) Renal Vein Swivel Blade, 1" x 6" (2.5cm x 15.2cm) Mayo Swivel Retractor, 2-3/4" x 2" (7cm x 5cm) RICHARDSON SWIVEL RETRACTOR, 3/4 X 1 MI RAKE RETRACTOR, 7/8 X 1/2 CURVED MINI RICHARDSON SWIVEL RETRACTOR, 1 X 2 MINI Renal Vein Retractor, Aluminum, 1" x 8" (2.5cm x 20.3cm) MAYO SWIVEL RETRACTOR, 2 X 2 MINI MAYO SWIVEL RETRACTOR, 2-3/4 X 2 MINI Renal Vein Retractor, 1" x 8" (2.5cm x 20.3cm) CRESCENT FRAME W/ARM, ONE PIECE, MINI Fence Swivel Retractor, 4" x 6" (10.2cm x 15.2cm) Renal Vein Swivel Retractor, 1" x 6" (2.5cm x 15.2cm) Deaver Swivel Retractor, 2-3/4" x 4-1/2" (7cm x 11.4cm) Renal Vein Swivel Retractor, 1" x 4-1/2" (2.5cm x 11.4cm) Malleable Slotted Swivel Retractor, 2" x 6-1/2" (5cm x 16.5c Malleable Slotted Swivel Retractor, 3" x 6-1/2" (7.6cm x 16. Harrington Sweetheart Swivel Retractor, 2" x 5" (5cm x 12.7c Harrington Sweetheart Swivel Retractor, 2-1/2" x 7" Splanchnic Swivel Retractor, 1-1/2" x 4" (3.8cm x 10.2cm) Anterior Swivel Retractor, 1-1/2" X 3" MINI Malleable Swivel Retractor, 3/4" X 2" MINI Malleable Swivel Retractor, 3/4" X 3" MINI Malleable Swivel Retractor, 3" X 4" MINI Malleable Swivel Retractor, 1" X 4" MINI Malleable Swivel Retractor, 1" X 5" MINI Malleable Swivel Retractor, 1" X 6" MINI Malleable Swivel Retractor, 1-1/2" X 3" MINI Malleable Swivel Retractor, 1-1/2" X 4" MINI Malleable Swivel Retractor, 1-1/2" X 5" MINI Malleable Swivel Retractor, 1-1/2" X 6" MINI Deaver Swivel Retractor, 1-1/2" x 6" (3.8cm x 15.2cm) Mayo Swivel Retractor, 2" x 2" (5cm x 5cm) Renal Vein Retractor, Aluminum, 1" x 6" (2.5cm x 15.2cm) WISHBONE, ADJUSTABLE W/ ANGLED ARM Aluminum, Renal Vein Swivel Retractor, 1" x 4" (2.5cm x 10.2) Aluminum, Renal Vein Swivel Retractor, 1" x 6" (2.5cm x 15.2) Aluminum, Renal Vein Swivel Retractor, 1" x 8" (2.5cm x 20.3) Renal Vein Swivel Retractor, 1" x 4" (2.5cm x 10.2cm) Renal Vein Swivel Blade 1" x 4" SS RENAL VEIN SWIVEL BLADE, 1" X 6" SS REN VEIN SWIVEL BLADE, 1" X 8" Renal Vein Retractor, 1" x 4" (2.5cm x 10.2cm) Renal Vein Retractor, 1" x 6" (2.5cm x 15.2cm) Renal Vein Retractor, 1" x 8" (2.5cm x 20.2cm) Malleable Swivel Retractor, 3/4" x 2" (1.9cm x 5cm) Malleable Swivel Retractor, 3/4" x 3" (1.9cm x 7.6cm) Malleable Swivel Retractor, 3/4" x 4" (1.9cm x 10.2cm) Posterior Swivel Retractor, 1-3/4" x 3" Posterior Swivel Retractor, 1-3/4" x 4" Harrington Sweetheart Blade, 2" X 5" (5cm X 12.7cm), ABH Sty Malleable Slotted Blade, 2" X 6.5" (5cm X 16.5cm), ABH Style Renal Vein Blade, 1" X 6" (2.5cm X 15.2cm), ABH Style Deaver Blade, 2.75" X 4.5" (7cm x 11.4cm), ABH Style Articulating Blade Holder with SnapClamp Splanchnic Blade, 2" X 6" (5cm X 15.2cm), ABH Style Fence Blade, 4" X 6" (10.2cm X 15.2cm), ABH Style
- Model Identifier(s)
- 10144R 10269 10270 11050 11121 11404R 11407 11409 3101R 3203 3216 3217 3335 3341R 3342 3343 3426 3483 3485 3530 3570 3772 3782 3784 3786 3788 3790 3794 3796 3798 3804R 3806R 3808R 3810R 3812 3814 3816 3818R 3820R 3822R 3824 3854R 3883R 3979 4020 4920R 4921 4922 4927 4931 4932 4933 4935 4936 4937 4964 4965 4966 4975 4976 11402 11403R 11405R 11400R 11610R 11406 11401R
About this record
Access comprehensive regulatory information for Integra™ Omni-Tract® Urologic Surgery Retractor Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014424 and owned by Integra LifeSciences Corporation. The device was registered on December 04, 2013.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B