Delta Xtend
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- DELTA XTEND EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Fluted Surgical Drill Bit, Single-Use EUDAMEDDELTA Xtend DRILL BIT Diameter 2,5 x 170 MM FDA UDI
- Model / Reference
- Fluted Surgical Drill Bit, Single-Use EUDAMED2307-90-005 EUDAMEDFDA UDI
- Description
- DELTA Xtend DRILL BIT Diameter 2,5 x 170 MM FDA UDI
Identifiers
- Catalog Number
- 230790005 FDA UDI
- Primary DI / UDI-DI
- 10603295116547 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0053796 EUDAMED
- Direct Marketing DI
- 10603295116547 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE 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
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Joint prosthesis implantation kit, single-use
Delta Xtend by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a0053796 | 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 4abc3bd2-2766-4eb3-af19-f113844aa238 61 fields · synced May 30, 2026
- FDA UDI d1fb6e00-3884-4873-9bc7-aa8f677f7836 35 fields · synced May 30, 2026