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Premium Plus 012W

by Premium Plus International Limited

Premium Plus 012W is a Class I device made by Premium Plus International Limited, listed in FDA GUDID since 27 Dec 2019 (UDI-DI D838012W2), 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 NumberD838012W2 UDI-DI Date27 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  • Withdrawn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
Surgical mist irrigation tip
Model / reference
012W
Primary DI / UDI-DI
D838012W2
FDA product code
NRD
GMDN term
Surgical mist irrigation tip
Device class
Class I
Regulation number
872.6640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical mist irrigation tip

Other devices from Premium Plus International Limited

See all devices from Premium Plus International Limited →

Properties

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