PremierPro 8326G
PremierPro 8326G is a Class II device made by Prestige Ameritech, listed in FDA GUDID since 25 Aug 2020 (UDI-DI 00818566010988), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00818566010988 | Date25 Aug 2020 | StatusListed |
Official records
- AccessGUDID record 00818566010988
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- PremierPro
- Generic name
- Patient surgical drape, single-use
- Model / Ref / Catalog
- 8326G
- Primary DI / UDI-DI
- 00818566010988
- FDA product code
- KKX, PUI
- GMDN term
- Patient surgical drape, single-use
- Device class
- Class II
- Regulation number
- 878.4370
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KKX (Drape, Surgical).
- STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE by MEDLINE INDUSTRIES, INC.
- ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650, D6651, D66XX by Medical Concepts Development, Inc.
- LINEN (HUCK) TOWEL by Dimed, Intl.
- QUALTEX TUBE/CORD ORGANIZER by DEROYAL INDUSTRIES, INC.
- NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H by Hinson and Hale Medical Technologies, Inc.
- CUSTOMED BASIC PACK I by Customed, Inc.
- WHITNEY MEDICAL SOLUTIONS ESHIELD by Whitney Medical Solutions
- MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES by MEDLINE INDUSTRIES, INC.
- IMC SURGICAL DRAPE by International Medsurg Connection
- ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP by Andronic Devices, Ltd.