FDA UDI
In Commercial Distribution
🇺🇸 United States
INHANCE
DI: 10603295549581
·
Model: 7103-00-500
·
DEPUY (IRELAND)
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INHANCE
- Primary DI
- 10603295549581
- Version / Model
- 7103-00-500
- Catalog Number
- 710300500
- 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
- 502bf3ba-16a0-4ca1-8aab-b763e67745dd
Device Description
INHANCE SHOULDER SYSTEM HYBRID UNITI GLENOID REVISION KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KIJ | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | General, Plastic Surgery | 878.4820 | 1 |
| HWA | IMPACTOR | Orthopedic | 888.4540 | 1 |
| HTO | REAMER | Orthopedic | 888.4540 | 1 |
| HWK | TREPHINE | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61781 | Joint prosthesis implantation kit, single-use | A collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603295549581 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]