Acufex

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: ACUFEX FDA UDI
Generic Name: Suture knot pusher, reusable FDA UDI
Device Name: MTO SUTURE PUSHER FDA UDI
Model / Reference: 7207772 FDA UDI
Description: MTO SUTURE PUSHER FDA UDI

Identifiers

Catalog Number: 7207772 FDA UDI
Primary DI / UDI-DI: 00885554009606 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Suture knot pusher, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

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: Suture knot pusher, reusable

Acufex by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suture knot pusher, reusable.

RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Hayden Medical — Hayden Medical Inc · Class II
PASHLEY LARYNGOSCOPE KNOT PUSHER — SONTEC INSTRUMENTS, INC. · Class I
Closed Knot Pusher — Biomet Orthopedics, Inc. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
MICTEC KNOT PUSHER — SONTEC INSTRUMENTS, INC. · Class II
V. Mueller — STERIS CORPORATION · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I

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: Smith & Nephew, Inc.

Sources (1)

FDA UDI fecc1318-4a66-4846-ace1-e165fd0d1302 35 fields · synced Jun 8, 2026