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Acufex 010600

by Smith & Nephew, Inc.

Acufex 010600 is a Class I device made by Smith & Nephew, Inc., listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010032607), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03596010032607 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Acufex
Generic name
Stereotactic surgery system probe, reusable
Model / Ref / Catalog
010600
Description
DISPOSABLE KNIFE HOOK STRAIGHT 3.0 MM BOX OF 5
Primary DI / UDI-DI
03596010032607
FDA product code
NBH
GMDN term
Stereotactic surgery system probe, reusable
Device class
Class I
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stereotactic surgery system probe, reusable

Similar devices in this category

Other devices filed under Stereotactic surgery system probe, reusable.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)