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Singapore HSA registration DE0014423

Integra™ Omni-Tract® Vascular Surgery Retractor Systems

Singapore flagSingapore·CLASS B·Integra LifeSciences Corporation·Registered December 04, 2013
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDB00109
HS Code
90189090
Registration information
Registration Number
DE0014423
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
Name
Integra LifeSciences Corporation
Short Name
Integra LifeSciences
Address
311 Enterprise Drive, Plainsboro, NJ 08536, UNITED STATES
Registrant
Name
HUMEDICAL (S) PTE. LTD.
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Name
HUMEDICAL (S) PTE. LTD.
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   Rake Assembly IMA, Blunt Teeth, Curved, 16-3/8" POST, IMA UPPER W/LUNG ARM CLAMP (4000) POST, LOWER, IMA Mayo Swivel Retractor, 2-3/4" x 2" (7cm x 5cm) Mayo Swivel Retractor, 3-1/2" x 2" (8.9cm x 5cm) Micro Adjust Knob Pittman IMA Rail Clamp, Bolt Assembly Pittman IMA Rail Clamp  Bent Pittman IMA Post  Adjustable T Post with Clamp Assemblies Rake Assembly IMA, Blunt Teeth, Squared, 16-3/8"  ARM ASSEMBLY, IMA Rake Assembly IMA, Sharp Teeth, Curved, 16-3/8" Fence Swivel Retractor, 4" x 6" (10.2cm x 15.2cm) Splanchnic Swivel Retractor, 2" x 6" ( 5cm x 15.2cm) Deaver Swivel Retractor, 2-3/4" x 4-1/2" (7cm 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 Splanchnic Swivel Retractor, 2" x 4-1/2" (5cm x 11.4cm) WISHBONE, ADJUSTABLE W/ ANGLED ARM SNAP CLAMP ASSEMBLY FASTSYSTEM STERILE FIELD POST Renal Vein Swivel Retractor, 1" x 6" (2.5cm x 15.2cm) Richardson Stoney Ret. Micro-Adjust, 3/4" x 2" (1.9cm x 5cm) Rake Retractor,, 7/8" x 1" (2.2cm x 2.5cm) Rake Retractor, 7/8" x 1/2" (2.2cm x 1.3cm) Richardson Swivel Retractor, 3/4" x 1" (1.9cm x 2.5cm) Richardson Swivel Retractor, 1" x 1" (2.5cm x 2.5cm) 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 3259R 3311R 3312 3335 3397R 3630 3631 3635 3640 3647 3650 3654 3765 3772 3774 3784 3788 3790 3794 3888 4020 4040 4080 4928 4956 4957 4958 4959 4960   11402   11403R   11405R    11400R    11610R     11406      11401R
About this record

Access comprehensive regulatory information for Integra™ Omni-Tract® Vascular 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 DE0014423 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.

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