← Back to catalogue
Enztec Short ORD – Locking – Bridgeback - Large AO
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 4250-7606
Identity
- Trade Name
- Enztec Short ORD - Locking - Bridgeback - Large AO EUDAMEDEnztec Short ORD – Locking – Bridgeback - Large AO FDA UDI
- Generic Name
- Surgical power tool adaptor FDA UDI
- Device Name
- Reamer Drivers and Acetabular Reamers EUDAMEDA surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 4250-7606 EUDAMEDFDA UDI
- Description
- A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4250-7606 FDA UDI
- Primary DI / UDI-DI
- 09421038411032 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN003022 EUDAMED
- Direct Marketing DI
- 09421038410929 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical power tool adaptor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- 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: Surgical power tool adaptor
Enztec Short ORD – Locking – Bridgeback - Large AO by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool adaptor.
- Offset reamer handle - Large AO - Tri coupling (NL) — INCIPIO DEVICES · Class I
- Offset reamer handle - Hudson motor shaft — INCIPIO DEVICES · Class I
- HAMMR™ — Biomet Orthopedics, Inc. · Class I
- Mod Inserter Connector — Zimmer, Inc. · Class I
- Carbon offset reamer handle Harris with parking — MPS Micro Precision Systems AG · Class I
- HAMMR™ — Biomet Orthopedics, Inc. · Class I
- Offset reamer handle - Dual coupling transmission (NL) — INCIPIO DEVICES · Class I
- Offset reamer handle - Hudson - Dual coupling — INCIPIO DEVICES · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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
- Enztec Limited
Sources (2)
- FDA UDI 4b0e0047-aeca-43b7-95c7-fcf4b7eebb3c 34 fields · synced Jun 19, 2026
- EUDAMED 08df234c-da7f-4cd2-af7d-1be6eb5e6c8b 61 fields · synced Jun 19, 2026