MedtechSourcebook

Intracardiac Patch Or Pledget, Biologically Derived (PSQ) contract manufacturers

8 US facilities list FDA product code PSQ as a contract manufacturer (2) or contract sterilizer (6).

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

FDA device name
Intracardiac Patch Or Pledget, Biologically Derived
Product code
PSQ (FDA product classification database)
Device class
Class II
Regulation
21 CFR 870.3470
Classification panel
Cardiovascular
FDA flags
implant

Where they are

Indiana 3 · California 1 · Illinois 1 · New Hampshire 1 · Pennsylvania 1 · South Carolina 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
COOK BIOTECH, INC.1835959Contract manufacturerCardiovascular; Neurology; OphthalmicWest Lafayette, INNot verifiedOct 21, 2026
COOK INCORPORATED1000393132Contract sterilizerGastroenterology and urology; General and plastic surgery; Cardiovascular +8 moreEllettsville, INNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.1047843Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Orthopedic +13 moreSpartanburg, SCNot verifiedOct 21, 2026
Isomedix Operations, Inc.1450662Contract sterilizerOrthopedic; General and plastic surgery; Cardiovascular +11 moreLibertyville, ILNot verifiedOct 21, 2026
LYOPHILIZATION SERVICES OF NEW ENGLAND, INC.1225991Contract manufacturerCardiovascular; General and plastic surgery; Neurology +1 moreManchester, NHNot verifiedOct 21, 2026
Sterigenics Radiation Technologies IN, Inc3009504230Contract sterilizerOrthopedic; General and plastic surgery; Cardiovascular +4 moreColumbia City, INNot verifiedOct 21, 2026
Synergy Health AST, LLC3009882464Contract sterilizerGeneral and plastic surgery; Cardiovascular; Clinical chemistry +6 moreSaxonburg, PANot verifiedOct 21, 2026
Synergy Health AST, LLC3012102437Contract sterilizerCardiovascular; General and plastic surgery; Orthopedic +6 morePetaluma, CANot verifiedOct 21, 2026

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