Identity
- Trade Name
- Duocentric® FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Device Name
- Bail out head FDA UDI
- Model / Reference
- 600020 FDA UDI
- Description
- Bail out head FDA UDI
Identifiers
- Catalog Number
- 30501941 FDA UDI
- Primary DI / UDI-DI
- 03663703001087 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head 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
Yes
FDA UDI
Category: Stem-fixed metallic humeral head prosthesis
Duocentric® by Aston Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Aston Medical
Sources (1)
- FDA UDI 31f6a3d4-8fa7-4bbc-847a-2243bfd83834 36 fields · synced May 30, 2026