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Bosma Enterprises 10-8020BIO2

by Bosma Enterprises

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818634025807 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Bosma Enterprises
Generic name
Operating room turnover kit
Model / Ref / Catalog
10-8020BIO2
Primary DI / UDI-DI
00818634025807
FDA product code
PWU
GMDN term
Operating room turnover kit
Device class
Class I
Regulation number
880.6890
GUDID distribution status
In Commercial Distribution

Other devices from Bosma Enterprises

See all devices from Bosma Enterprises →

Properties

  • Single use
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No