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PEA OxyPlate O-PEA-BA

by Oxyrase, 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 Number00850056467124 UDI-DI Date14 Oct 2025ListedStatusListed 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  • Withdrawn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
PEA OxyPlate
Generic Name
Differential/selective agar culture medium IVD
Model / Ref / Catalog
O-PEA-BA
Primary DI / UDI-DI
00850056467124
FDA Product Code
JSJ
GMDN Term
Differential/selective agar culture medium IVD
Device Class
Class I
Regulation Number
866.2360
GUDID distribution status
In Commercial Distribution
Size
Weight — 24 Gram

Other devices from Oxyrase, Inc.

See all devices from Oxyrase, Inc. →

Properties

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

Other properties (8)

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