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PremierPro 7045

by Prestige Ameritech

PremierPro 7045 is a Class I device made by Prestige Ameritech, listed in FDA GUDID since 29 Aug 2020 (UDI-DI 00818566017130), 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 Number00818566017130 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  • Withdrawn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
Cast construction material
Model / Ref / Catalog
7045
Primary DI / UDI-DI
00818566017130
FDA product code
ITG
GMDN term
Cast construction material
Device class
Class I
Regulation number
890.3025
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ITG (Bandage, Cast).

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)