Enztec ORD - Corin - Open - Zimmer

FDA UDIEUDAMED

Class I (US FDA UDI)

by Enztec Limited

Identity

Trade Name: Enztec ORD - Corin - Open - Zimmer FDA UDI
Generic Name: Surgical power tool adaptor FDA UDI
Device Name: A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure FDA UDI
Model / Reference: 3991066 FDA UDI
Description: A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure FDA UDI

Identifiers

Catalog Number: 3991066 FDA UDI
Primary DI / UDI-DI: 09421028111188 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Surgical power tool adaptor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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 power tool adaptor

Enztec ORD - Corin - Open - Zimmer 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

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 b4ed7917-7430-4820-877e-26e9fa9e8246 34 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 18, 2026