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Global Unite
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 2100-40-017Model Humeral Body Prosthesis Trial
Identity
- Trade Name
- GLOBAL UNITE EUDAMEDFDA UDI
- Generic Name
- Humeral body prosthesis trial FDA UDI
- Device Name
- Humeral Body Prosthesis Trial EUDAMEDGLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 142 DEGREE SIZE 12 FDA UDI
- Model / Reference
- 2100-40-017 EUDAMEDFDA UDIHumeral Body Prosthesis Trial EUDAMED
- Description
- GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 142 DEGREE SIZE 12 FDA UDI
Identifiers
- Catalog Number
- 210040017 FDA UDI
- Primary DI / UDI-DI
- 10603295416166 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a000968V EUDAMED
- Direct Marketing DI
- 10603295416166 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Humeral body prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Humeral body prosthesis trial
Global Unite by Depuy (ireland) — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (2)
- FDA UDI 4c7fb024-4843-4940-874c-dc2888ab3119 35 fields · synced Oct 6, 2026
- EUDAMED e3480227-bcb4-4ef7-a7e0-2ffa4dfb3f7d 61 fields · synced Sep 30, 2026