Enztec MIH Left Acetabular Retractor
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec MIH Left Acetabular Retractor EUDAMEDFDA UDIAcetabular Retractor Left EUDAMEDFDA UDI
- Generic Name
- Hand-held surgical retractor, reusable 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
- 4050-0005 EUDAMEDFDA UDI9095.11.908 EUDAMEDFDA UDI
- Description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4050-0005 FDA UDI9095.11.908 FDA UDI
- Primary DI / UDI-DI
- 09421028111928 EUDAMEDFDA UDI09421028111836 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN003124 EUDAMED
- Direct Marketing DI
- 09421028111836 EUDAMED09421028111928 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
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: Hand-held surgical retractor, reusable
Enztec MIH Left Acetabular Retractor by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 (4)
- FDA UDI 69a9c985-e056-4f48-833b-b693d6f2ac35 34 fields · synced Aug 1, 2026
- FDA UDI 24646240-1760-463d-b92c-9d358d851f25 34 fields · synced May 30, 2026
- EUDAMED 0174fc93-6de0-45b4-a9a3-1ea4d779acdc 61 fields · synced Jul 9, 2026
- EUDAMED d3c2f807-f295-4681-bf78-23fd63dceef8 61 fields · synced Jul 28, 2026