FDA UDI
In Commercial Distribution
🇺🇸 United States
INHANCE
DI: 10603295549147
·
Model: 5100-29-022
·
DEPUY (IRELAND)
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INHANCE
- Primary DI
- 10603295549147
- Version / Model
- 5100-29-022
- Catalog Number
- 510029022
- Company Name
- DEPUY (IRELAND)
- Labeler DUNS
- 989365556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-28
- Public Version
- 1
- Public Version Date
- 2023-03-08
- Public Version Status
- New
- Public Device Record Key
- fea48c02-91e7-4acb-a968-49270ab25ebc
Device Description
INHANCE SHOULDER SYSTEM HYBRID UNITI GLENOID LARGE Ø29mm CEMENTED CAUTION:INTENDED FOR CEMENTED USE ONLY
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3650 | 2 |
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| MBF | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | Orthopedic | 888.3670 | 2 |
| PAO | prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented | Orthopedic | 888.3660 | 2 |
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | Orthopedic | 888.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36259 | Shoulder glenoid fossa prosthesis, prefabricated | An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603295549147 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212933 | 000 |