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BF538

by Steris Corporation

BF538 is a Class I device made by Steris Corporation, listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00724995165376), 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 Number00724995165376 UDI-DI Date23 Apr 2021ListedStatusListed 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  • Withdrawn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

Generic name
Traction boot
Model / Ref / Catalog
BF538
Primary DI / UDI-DI
00724995165376
FDA product code
HST
GMDN term
Traction boot
Device class
Class I
Regulation number
888.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Traction boot

Similar devices

Other devices filed under FDA product code HST (Apparatus, traction, non-powered).

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Over-the-counter
  • Premarket exempt
  • Manufacturing date
Other properties (12, all answered No)