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Attune
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2544-01-003Model SIGMA Instrument/Implant Impactor, Knee
Identity
- Trade Name
- ATTUNE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Instrument/Implant Impactor, Knee EUDAMEDATTUNE TIBIAL IMPACTOR FIXED BEARING FDA UDI
- Model / Reference
- SIGMA Instrument/Implant Impactor, Knee EUDAMED2544-01-003 EUDAMEDFDA UDI
- Description
- ATTUNE TIBIAL IMPACTOR FIXED BEARING FDA UDI
Identifiers
- Catalog Number
- 254401003 FDA UDI
- Primary DI / UDI-DI
- 10603295130192 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a003999J EUDAMED
- Direct Marketing DI
- 10603295130192 EUDAMED
- FDA Product Code
- HWA FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
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
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: Orthopaedic implant impactor, reusable
Attune by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0603295a003999J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 817220e3-1c55-4c45-98e1-a1236041bcbb 61 fields · synced Jun 8, 2026
- FDA UDI 62f6df76-ca4b-4c9a-bdf6-7e7cdb22408b 35 fields · synced May 30, 2026