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Batrik Bitestrong Bite Blocks BO2

by Batrik Medical Manufacturing Inc

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690521000100 UDI-DI Date25 Sep 2020ListedStatusListed 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  • Withdrawn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
Batrik Bitestrong Bite Blocks
Generic Name
Endoscopic bite block, basic, single-use
Model / Ref / Catalog
BO2
Primary DI / UDI-DI
00690521000100
FDA Product Code
MNK
GMDN Term
Endoscopic bite block, basic, single-use
Device Class
Class I
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

Other devices from Batrik Medical Manufacturing Inc.

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No