Enztec Charnley - Spiked Fixed Blade Retractor – 100mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec Charnley - Spiked Fixed Blade Retractor - 100mm EUDAMEDEnztec Charnley - Spiked Fixed Blade Retractor – 100mm 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 UDI
- Model / Reference
- 4050-0193 EUDAMEDFDA UDI
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4050-0193 FDA UDI
- Primary DI / UDI-DI
- 09421028117012 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN003124 EUDAMED
- Direct Marketing DI
- 09421028117012 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
- 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 - Spiked Fixed Blade Retractor – 100mm 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
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- 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 (2)
- FDA UDI b6e15664-419e-4ac4-827f-f8b651fcbd99 34 fields · synced Jul 25, 2026
- EUDAMED ea50c7ed-2a28-4844-8b70-5bfbef9b958e 61 fields · synced Jul 25, 2026