Identity
- Trade Name
- Bone Hook EUDAMEDFDA UDI
- Generic Name
- Bone hook FDA UDI
- Device Name
- Retractors and Frames EUDAMEDA reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- ME-BH0001 EUDAMEDFDA UDI
- Description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- ME-BH0001 FDA UDI
- Primary DI / UDI-DI
- 09421028119108 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN003124 EUDAMED
- Direct Marketing DI
- 09421028119108 EUDAMED
- FDA Product Code
- KIK FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Bone hook FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- 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: Bone hook
Bone Hook by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone hook.
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- Novo Surgical Inc — NOVO SURGICAL, INC. · Class I
- AESCULAP — AESCULAP, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- GELPI NEROMA RETRACTOR — SONTEC INSTRUMENTS, INC. · 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 |
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Manufacturer
- Manufacturer
- Enztec Limited
Sources (2)
- FDA UDI e4ee4eab-3473-45ca-9dfe-413ccd43d6cf 34 fields · synced Sep 18, 2026
- EUDAMED 41b3b4cb-6688-4499-aa22-dcba39e472f2 61 fields · synced Sep 18, 2026