Enztec MIH Hohmann Long Retractor
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec MIH Hohmann Retractor EUDAMEDFDA UDIEnztec MIH Hohmann Long Retractor FDA 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
- 4050-0002 EUDAMEDFDA UDI4050-0004 FDA UDI
- Description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4050-0004 FDA UDI4050-0002 FDA UDI
- Primary DI / UDI-DI
- 09421028113397 EUDAMEDFDA UDI09421028113410 FDA UDI
- Basic UDI-DI
- 942102811GMN003124 EUDAMED
- Direct Marketing DI
- 09421028113397 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 Hohmann Long 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 (3)
- FDA UDI 0001229d-cf2f-40d5-a857-620108468ce1 34 fields · synced Jul 9, 2026
- FDA UDI 7c2adf5d-5a67-444d-b9b2-9450fad83121 34 fields · synced May 30, 2026
- EUDAMED aeb8bff5-30f2-4af7-a373-3b2671528a82 61 fields · synced Jul 9, 2026