Skip to content

PremierPro 2815T

by Prestige Ameritech

PremierPro 2815T is a Class I device made by Prestige Ameritech, listed in FDA GUDID since 30 Jul 2020 (UDI-DI 00818566019974), 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 Number00818566019974 UDI-DI Date30 Jul 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  • Withdrawn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
Isolation gown, single-use
Model / Ref / Catalog
2815T
Primary DI / UDI-DI
00818566019974
FDA product code
OEA
GMDN term
Isolation gown, single-use
Device class
Class I
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Isolation gown, single-use

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

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