← Back to catalogue
Depuy Orthopaedic Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2570-04-503Model DEPUY ORTHOPAEDIC INSTRUMENTS Calcar Planer, Hip
Identity
- Trade Name
- DEPUY ORTHOPAEDIC INSTRUMENTS EUDAMEDNA FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Calcar Planer, Hip EUDAMEDMODULAR CALCAR PLANER 48mm Diameter FDA UDI
- Model / Reference
- DEPUY ORTHOPAEDIC INSTRUMENTS Calcar Planer, Hip EUDAMED2570-04-503 EUDAMEDFDA UDI
- Description
- MODULAR CALCAR PLANER 48mm Diameter FDA UDI
Identifiers
- Catalog Number
- 257004503 FDA UDI
- Primary DI / UDI-DI
- 10603295482031 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004689C EUDAMED
- Direct Marketing DI
- 10603295482031 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 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
Yes
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: Acetabular orthopaedic reamer
Depuy Orthopaedic Instruments by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabular orthopaedic reamer.
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Viant Medical, LLC — Viant Medical, LLC · Class I
- ACETABULAR REAMER D53 mm HC — HPF SRL · Class I
- Flexible Reamer Ø14 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
- ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- U2 Total Knee System — United Orthopedic Corporation · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a004689C | Class I | Active |
| 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 UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 5bb26b88-fef3-4c3a-aee6-65c567a55951 61 fields · synced Jun 18, 2026
- FDA UDI 2a2219cf-c447-4d93-ae18-34b7a4a19444 35 fields · synced May 30, 2026