ACUFEX Meniscal Root Repair

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: ACUFEX Meniscal Root Repair FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE FDA UDI
Model / Reference: 71935068 FDA UDI
Description: MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE FDA UDI

Identifiers

Catalog Number: 71935068 FDA UDI
Primary DI / UDI-DI: 00885556533277 FDA UDI
FDA Product Code: MAI FDA UDI
GAT FDA UDI
NBI FDA UDI
LXH FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
878.5000 FDA UDI
888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable Polyolefin/fluoropolymer suture, multifilament Suturing unit, single-use

ACUFEX Meniscal Root Repair by Smith & Nephew, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 31c9cec3-8045-4e37-9cdf-e325452c622c 35 fields · synced Jun 8, 2026