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PremierPro 8986

by Prestige Ameritech

PremierPro 8986 is a Class I device made by Prestige Ameritech, listed in FDA GUDID since 29 Aug 2020 (UDI-DI 00818566016850), 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 Number00818566016850 UDI-DI Date29 Aug 2020ListedStatusListed 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  • Withdrawn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
PremierPro
Generic name
Non-adhesive device retention bandage
Model / Ref / Catalog
8986
Primary DI / UDI-DI
00818566016850
FDA product code
FQM, KGX
GMDN term
Non-adhesive device retention bandage
Device class
Class I
Regulation number
880.5075, 880.5240
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FQM (Bandage, Elastic).

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Supplied sterile
  • Single use
  • Contains latex
  • Premarket exempt
Other properties (11, all answered No)