MedtechSourcebook

Biopsy Needle Guide Kit (OIJ) contract manufacturers

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

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

FDA device name
Biopsy Needle Guide Kit
Product code
OIJ (FDA product classification database)
Device class
Class II
Regulation
21 CFR 892.1560
Classification panel
Radiology

Where they are

Texas 3 · California 1 · North Carolina 1 · Pennsylvania 1

All 6 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
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 LLC2011171Contract sterilizerCardiovascular; General and plastic surgery; General hospital +13 moreLos Angeles, CANot verifiedOct 21, 2026
Sterigenics US LLC3004111573Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreGrand Prairie, TXNot verifiedOct 21, 2026
TRANSDUCERWORKS3008640801Contract manufacturerRadiologyCentre Hall, PANot verifiedOct 21, 2026

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