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ecoFIX

by S.B.M 3 variants

ecoFIX (EPA9000008) is a Class I device made by S.B.M, listed in FDA GUDID since 12 Jun 2024 (UDI-DI 03760304681288), not in commercial distribution (GUDID) as of 1 Jun 2026.

Listed FDA GUDID listing, not in commercial distribution

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 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760304681288 UDI-DI Date12 Jun 2024ListedStatusListed GUDID: not 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  • Withdrawn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

Generic name
Arthroscopic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
Complete ecoFIX basket - 1st and 2nd rows with automatic grasper, EPA9000008
Primary DI / UDI-DI
03760304681288
FDA product code
LXH
GMDN term
Arthroscopic surgical procedure kit, non-medicated, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)