Enztec Charnley - Spiked Retractor – 100mm

FDA UDIEUDAMED

Class I (US FDA UDI)

by Enztec Limited

Identity

Trade Name: Enztec Charnley - Spiked Retractor – 100mm FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Model / Reference: 4050-0173 FDA UDI
Description: A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI

Identifiers

Catalog Number: 4050-0173 FDA UDI
Primary DI / UDI-DI: 09421028116930 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Surgical retraction system, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retraction system, reusable

Enztec Charnley - Spiked 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

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 fd9788f7-f4aa-4296-b290-5e2cf0b5e322 34 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026