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Intuition For Hp Partial
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2525-45-005Model SIGMA HP Partial Pin Pack
Identity
- Trade Name
- INTUITION FOR HP PARTIAL EUDAMEDINTUITION FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Pin Pack EUDAMEDINTUITION FOR HP PARTIAL PIN PACK FDA UDI
- Model / Reference
- SIGMA HP Partial Pin Pack EUDAMED2525-45-005 EUDAMEDFDA UDI
- Description
- INTUITION FOR HP PARTIAL PIN PACK FDA UDI
Identifiers
- Catalog Number
- 252545005 FDA UDI
- Primary DI / UDI-DI
- 10603295547860 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a003568Y EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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: Orthopaedic guidewire, single-use
Intuition For Hp Partial by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic guidewire, single-use.
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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 | 0603295a003568Y | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED ebcea2a4-de2b-4f44-b985-f95392ca55b4 61 fields · synced Jun 8, 2026
- FDA UDI 3faafcbc-1b8d-4eff-b2f7-fef9ea3be871 35 fields · synced May 30, 2026