Singapore HSA registration DE0509883
Grace Medical De La Cruz Pistons Stapes Prostheses
Singapore·CLASS C·Grace Medical, Inc.·Registered October 08, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0509883
- Registration Date
- October 08, 2024
- Retention Due Date
- October 07, 2025
Product description
Stapes replacement prostheses are surgically implanted into the middle ear as replacements for an immobile stapes due to otosclerosis. Piston or Bucket Handle prostheses function as a mechanical trans-former and transmit sound energy from the incus to the oval window of the cochlea. INDICATIONS 1. Chronic middle ear disease 2. Otosclerosis 3. Congenital fixation of the stapes 4. Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery 5. Surgically correctable injury to the middle ear from trauma
Product Owner
- Short Name
- Grace Medical, Inc.
- Address
- 8500 Wolf Lake Drive, Suite 110, Memphis, Tennessee, 38133, UNITED STATES
Registrant
- Address
- 11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
- Address
- 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model information
- Model Name(s)
- DE LA CRUZ PISTON 0.6MM DIA. X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC DE LA CRUZ PISTON 0.6MM DIA. X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC DE LA CRUZ PISTON 0.6MM DIA. X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC DE LA CRUZ PISTON 0.6MM DIA. X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC DE LA CRUZ PISTON 0.6MM DIA. X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC
- Model Identifier(s)
- 415-375 415-400 415-425 415-450 415-475
About this record
Access comprehensive regulatory information for Grace Medical De La Cruz Pistons Stapes Prostheses in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509883 and owned by Grace Medical, Inc.. The device was registered on October 08, 2024.
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 C