Identity
- Trade Name
- GLOBAL CAP FDA UDI
- Generic Name
- Partial shoulder prosthesis FDA UDI
- Device Name
- GLOBAL CAP HEAD DUOFIX HA PC SIZE 40 x 15 FDA UDI
- Model / Reference
- 1230-40-005 FDA UDI
- Description
- GLOBAL CAP HEAD DUOFIX HA PC SIZE 40 x 15 FDA UDI
Identifiers
- Catalog Number
- 123040005 FDA UDI
- Primary DI / UDI-DI
- 10603295017691 FDA UDI
- 510(k) Number
- K033516 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Partial shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Partial shoulder prosthesis
Global Cap by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K033516 also covers:
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI be8698ed-60d1-4d00-b08d-d835e836b162 36 fields · synced Jun 6, 2026