Enztec Reamer - Bridgeback - Sz49

FDA UDI

Class I (US FDA UDI)

by Enztec Limited

Identity

Trade Name: Enztec Reamer - Bridgeback - Sz49 FDA UDI
Generic Name: Acetabular orthopaedic reamer 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: 4250-7149 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: 4250-7149 FDA UDI
Primary DI / UDI-DI: 09421028112031 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Acetabular orthopaedic reamer 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: Acetabular orthopaedic reamer

Enztec Reamer - Bridgeback - Sz49 by Enztec Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Enztec Limited

Sources (1)

FDA UDI d08a9a01-fea2-4cb5-9a7c-04df7c8218db 34 fields · synced Jun 8, 2026