Skip to content

BioXtra 90077647

by Orabio, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00850083135027 UDI-DI Date23 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BioXtra
Generic Name
Oropharyngeal mucosa protection material
Model / Reference
90077647
Primary DI / UDI-DI
00850083135027
510(k) Number
FDA Product Code
LFD
GMDN Term
Oropharyngeal mucosa protection material
Device Class
U
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 40 Milliliter

Related devices

Cleared under the same submission (K072306)

Other devices from Orabio, Inc.

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No