← Back to catalogue
Depuy Synthes
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 4830-36-085Model DEPUY SYNTHES Trial Head Prosthesis, Hip
Identity
- Trade Name
- DEPUY SYNTHES FDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Device Name
- Trial Head Prosthesis, Hip EUDAMEDDEPUY SYNTHES 36 MM +8.5 TRIAL HEAD FDA UDI
- Model / Reference
- DEPUY SYNTHES Trial Head Prosthesis, Hip EUDAMED4830-36-085 EUDAMED483036085 FDA UDI
- Description
- DEPUY SYNTHES 36 MM +8.5 TRIAL HEAD FDA UDI
Identifiers
- Catalog Number
- 483036085 FDA UDI
- Primary DI / UDI-DI
- 10603295509325 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005879M EUDAMED
- Direct Marketing DI
- 10603295509325 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral head 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
No
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
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
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: Femoral head prosthesis trial
Depuy Synthes by Depuy (ireland) — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Femoral head prosthesis trial.
- BI-METRIC(R) HEAD/NECK PROVISIONAL — Biomet Orthopedics, Inc. · Class I
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- CHARNLEY — DEPUY INTERNATIONAL LTD · Class I
- Klassic Femoral Head Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- AcuMatch — Exactech, Inc. · Class I
- G7® — Biomet Orthopedics, Inc. · Class II
- AcuMatch — Exactech, Inc. · Class I
- NovoHip Total Hip System — Novosource, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (2)
- FDA UDI f544ae72-1e71-4787-9017-90c850dd0db0 35 fields · synced Oct 9, 2026
- EUDAMED d0314864-0ccc-48c9-9818-bbca0c444086 61 fields · synced Oct 9, 2026