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Premium Plus 653-19-LM

by Premium Plus International Limited

Premium Plus 653-19-LM is an instrument tray (FDA Class I; FDA product code FSM, Tray, Surgical, Instrument) made by Premium Plus International Limited, listed in FDA GUDID since 30 Dec 2019 (UDI-DI D83865319LM4), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD83865319LM4 UDI-DI Date30 Dec 2019ListedStatusListed 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  • Withdrawn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
Premium Plus
Generic name
Instrument tray, reusable
Model / reference
653-19-LM
Primary DI / UDI-DI
D83865319LM4
FDA product code
FSM
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)