Identity
- Trade Name
- DELTA XTEND FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- DELTA XTEND Central Screw Metaglene augmented metaglene reamer inner drive shaft tip FDA UDI
- Model / Reference
- 2317-70-824 FDA UDI
- Description
- DELTA XTEND Central Screw Metaglene augmented metaglene reamer inner drive shaft tip FDA UDI
Identifiers
- Catalog Number
- 231770824 FDA UDI
- Primary DI / UDI-DI
- 10603295537977 FDA UDI
- FDA Product Code
- KIJ FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone-resection orthopaedic reamer, single-use
Delta Xtend by Depuy (ireland) — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (1)
- FDA UDI f4c36204-41b7-4a29-8bec-bd7eb18b1520 35 fields · synced Jun 1, 2026