Enztec Charnley - Clawed Fixed Blade Retractor – 75mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec Charnley - Clawed Retractor - 75mm EUDAMEDEnztec Charnley - Clawed Fixed Blade Retractor - 75mm EUDAMEDEnztec Charnley - Clawed Fixed Blade Retractor – 75mm FDA UDIEnztec Charnley - Clawed Retractor – 75mm FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Retractors and Frames EUDAMEDA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIA reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 4050-0182 EUDAMEDFDA UDI4050-0162 EUDAMEDFDA UDI
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIA reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4050-0182 FDA UDI4050-0162 FDA UDI
- Primary DI / UDI-DI
- 09421028116961 EUDAMEDFDA UDI09421028116886 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN003124 EUDAMED
- Direct Marketing DI
- 09421028116886 EUDAMED09421028116961 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Surgical retraction system, 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: Surgical retraction system, reusable
Enztec Charnley - Clawed Fixed Blade Retractor – 75mm by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
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- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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 b4165bdd-b4c3-4ea3-b722-194383a5003f 34 fields · synced Jul 15, 2026
- FDA UDI 08ee2c1b-be8a-4c52-940c-bd99d8b91299 34 fields · synced May 30, 2026
- EUDAMED f9b1725b-5177-4324-ab90-675c4dae43a6 61 fields · synced Jul 10, 2026
- EUDAMED d26f377c-6722-4e95-993c-4a5f2b104f48 61 fields · synced Jul 15, 2026