MedtechSourcebook

Percutaneous Sheath Introducer Kit (OFL) contract manufacturers

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

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

FDA device name
Percutaneous Sheath Introducer Kit
Product code
OFL (FDA product classification database)
Device class
Class II
Regulation
21 CFR 870.1340
Classification panel
Cardiovascular

Where they are

Texas 3 · Georgia 1 · Missouri 1 · North Carolina 1 · Pennsylvania 1

All 7 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
B. BRAUN US DEVICE MANUFACTURING LLC2523676Contract manufacturerGeneral hospital; Anesthesiology; General and plastic surgery +6 moreAllentown, PANot 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
MIDWEST STERILIZATION CORP.1928237Contract sterilizerGeneral and plastic surgery; Cardiovascular; General hospital +14 moreJackson, MONot verifiedOct 21, 2026
Sterigenics U.S., LLC1018470Contract sterilizerGeneral and plastic surgery; Orthopedic; General hospital +12 moreAtlanta, GANot 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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