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Enztec Straight Reamer Driver – Locking – Bridgeback – Mini Zimmer
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 4250-7380
Identity
- Trade Name
- Enztec Straight Reamer Driver - Locking - Bridgeback - Mini Zimmer EUDAMEDEnztec Straight Reamer Driver – Locking – Bridgeback – Mini Zimmer 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
- 4250-7380 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
- 4250-7380 FDA UDI
- Primary DI / UDI-DI
- 09421028117340 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN003022 EUDAMED
- Direct Marketing DI
- 09421028117340 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 Straight Reamer Driver – Locking – Bridgeback – Mini Zimmer by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Surgical power tool adaptor.
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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 |
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Manufacturer
- Manufacturer
- Enztec Limited
Sources (2)
- FDA UDI e2106a54-acd1-4c97-809d-64a298651f65 34 fields · synced Jul 16, 2026
- EUDAMED 9f8e3d05-1463-461e-b4c4-3494d1571c0c 61 fields · synced Jul 16, 2026