FDA UDI
In Commercial Distribution
🇺🇸 United States
INHANCE SHOULDER SYSTEM
DI: 10603295560050
·
Model: 7500-10-106
·
DEPUY (IRELAND)
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INHANCE SHOULDER SYSTEM
- Primary DI
- 10603295560050
- Version / Model
- 7500-10-106
- Catalog Number
- 750010106
- Company Name
- DEPUY (IRELAND)
- Labeler DUNS
- 989365556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-21
- Public Version
- 1
- Public Version Date
- 2025-03-03
- Public Version Status
- New
- Public Device Record Key
- 32fdd52d-5bfa-45b0-87ca-98de64e7e87f
Device Description
INHANCE SHOULDER SYSTEM DRIVER NA NA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
| HWR | DRIVER, PROSTHESIS | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61807 | Bone-resection orthopaedic reamer, single-use | An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603295560050 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]