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Activa Instrument B-IRC-4004

by Bioretec Oy

Activa Instrument B-IRC-4004 is a Class I device made by Bioretec Oy, listed in FDA GUDID since 17 Sep 2026 (UDI-DI 06438394020399), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06438394020399 UDI-DI Date17 Sep 2026ListedStatusListed 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  • Withdrawn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
Activa Instrument
Generic name
Surgical countersink, reusable
Model / Ref / Catalog
B-IRC-4004
Primary DI / UDI-DI
06438394020399
FDA product code
LXH
GMDN term
Surgical countersink, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code LXH (Orthopedic Manual Surgical Instrument).

Other devices from Bioretec Oy

See all devices from Bioretec Oy →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)