FDA UDI
In Commercial Distribution
🇺🇸 United States
Austin / Polycel®
DI: 00763000035396
·
Model: 1156305
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Austin / Polycel®
- Primary DI
- 00763000035396
- Version / Model
- 1156305
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-07
- Public Version
- 1
- Public Version Date
- 2021-11-15
- Public Version Status
- New
- Public Device Record Key
- b05b7f29-81b8-4ef5-b27e-59eb458a270e
Device Description
PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LBM | POROUS POLYETHYLENE OSSICULAR REPLACEMENT | Ear, Nose, Throat | 874.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35674 | Ossicular prosthesis, total | A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000035396 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K823441 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Shaft Diameter = 0.6 mm | ||
| Length | 8.0 | Millimeter | |
| Device Size Text, specify | Head Diameter = 3 mm |