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Trinity Sterile, Inc. 85287UMROI

by Trinity Sterile, Inc.

Trinity Sterile, Inc. 85287UMROI is a Class II device made by Trinity Sterile, Inc., listed in FDA GUDID since 31 Aug 2023 (UDI-DI 10841767107451), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841767107451 UDI-DI Date31 Aug 2023ListedStatusListed 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  • Withdrawn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

Trade name
Trinity Sterile, Inc.
Generic name
Oral care kit, single-use
Model / reference
85287UMROI
Primary DI / UDI-DI
10841767107451
FDA product code
LRO
GMDN term
Oral care kit, single-use
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Oral care kit, single-use

Other devices from Trinity Sterile, Inc.

See all devices from Trinity Sterile, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (8, all answered No)