FDA UDI
In Commercial Distribution
🇺🇸 United States
Arthrex®
DI: 00888867406452
·
Model: AR-9502-33ARCA
·
ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Arthrex®
- Primary DI
- 00888867406452
- Version / Model
- AR-9502-33ARCA
- Catalog Number
- AR-9502-33ARCA
- Company Name
- ARTHREX, INC.
- Labeler DUNS
- 131747628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-29
- Public Version
- 3
- Public Version Date
- 2025-11-17
- Public Version Status
- Update
- Public Device Record Key
- c34fbcdd-c21d-413b-b801-8341f8312d6a
Device Description
CA Humeral Head Adapter 33 mm
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 |
|---|---|---|---|---|
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | Orthopedic | 888.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61004 | Shoulder reverse/standard adaptor prosthesis | A sterile implantable component of a total shoulder prosthesis intended to be used in the revision surgery of a reverse shoulder prosthesis to avoid replacement of the humeral body/stem by enabling articulation between a reverse shoulder body and a standard humeral head [typically a cuff tear arthropathy (CTA) head]. It is a double male taper made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)] and is used in a modular shoulder replacement system. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888867406452 | GS1 |
Customer Contacts
- Phone
- +1(800)934-4404
- [email protected]