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Premium Plus 308-ASS

by Premium Plus International Limited

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 NumberD838308ASS2 UDI-DI Date25 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  • Withdrawn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
Dental suction system cannula, single-use
Model / reference
308-ASS
Primary DI / UDI-DI
D838308ASS2
FDA product code
GEA
GMDN term
Dental suction system cannula, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Other devices from Premium Plus International Limited

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No