ExSept Plus 500 mL

• FDA 510(k) K082858 decided 27 May 2009 Active
• FDA GUDID UDI-DI 00898021000075 listed 29 Aug 2016 Listed

1. 27 May 2009 Cleared FDA 510(k) K082858
2. 29 Aug 2016 Listed FDA GUDID 00898021000075

Trade name

ExSept Plus

Generic name

Antimicrobial wound irrigation solution

Model / Ref / Catalog

500 mL, 15117

Primary DI / UDI-DI

00898021000075

510(k) Number

K082858 ↗

FDA product code

FQH

GMDN term

Antimicrobial wound irrigation solution

Device class

Class II

Regulation number

880.5475

GUDID distribution status

In Commercial Distribution

Category: Antimicrobial wound irrigation solution

Other devices filed under FDA product code FQH (Lavage, Jet).

• ERBE 20150-230 by Erbe Elektromedizin GmbH
• ERBE 20325-100 by Erbe Elektromedizin GmbH
• Next Science Irrigation Solution by Next Science LLC
• HELIX HYDRO-JET by Andreas Pein Medizintechnik GmbH
• VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE by Smith & Nephew Wound Management
• PulsaClean W-203-B(CM039) LD 1000 by Guangzhou Clean Medical Products Manufacturing Corp.
• VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH by Smith & Nephew, Inc.
• EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER by Alcavis International, Inc.
• Armis VeriCyn Wound Wash by ARMIS BIOPHARMA, INC.
• ACKRAD N-DO VAGE TUBE by Ackrad Laboratories

• Peracidin™ Gallon

  Class II

  FDA 510(k) K962959 Active Cleared 5 Jun 1998 GUDID on market

• ExSept Plus 250 mL

  Class II

  FDA 510(k) K082858 Active Cleared 27 May 2009 GUDID on market

• Peracidin™ Quarts

  Class II

  FDA 510(k) K962959 Active Cleared 5 Jun 1998 GUDID on market

• ExSept Plus 200 mL Spray

  Class II

  FDA 510(k) K082858 Active Cleared 27 May 2009 GUDID on market

See all devices from Angelini Pharma Inc. →