MedtechSourcebook

Gastro-Urology Biopsy Kit (PRV) contract manufacturers

5 US facilities list FDA product code PRV as a contract manufacturer (1) or contract sterilizer (4).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Gastro-Urology Biopsy Kit
Product code
PRV (FDA product classification database)
Device class
Class II
Regulation
21 CFR 876.1075
Classification panel
Gastroenterology and urology

Where they are

Texas 3 · Connecticut 1 · North Carolina 1

All 5 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
AERO-MED LLC3006191977Contract manufacturerGeneral hospital; Pathology; General and plastic surgery +4 moreEast Hartford, CTNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC1643817Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +14 moreEl Paso, TXNot verifiedOct 21, 2026
Isomedix Operations Inc3009888344Contract sterilizerGastroenterology and urology; General and plastic surgery; General hospital +13 moreEl Paso, TXNot verifiedOct 21, 2026
Sterigenics U.S., LLC1061124Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreCharlotte, NCNot verifiedOct 21, 2026
Sterigenics US LLC3004111573Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreGrand Prairie, TXNot verifiedOct 21, 2026

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