MedtechSourcebook

Dura Substitute (GXQ) contract manufacturers

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

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

FDA device name
Dura Substitute
Product code
GXQ (FDA product classification database)
Device class
Class II
Regulation
21 CFR 882.5910
Classification panel
Neurology
FDA flags
implant

Where they are

New York 2 · California 1 · Indiana 1 · New Hampshire 1 · New Jersey 1 · Puerto Rico 1 · South Carolina 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
COOK INCORPORATED1000393132Contract sterilizerGastroenterology and urology; General and plastic surgery; Cardiovascular +8 moreEllettsville, INNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.1319660Contract sterilizerOrthopedic; General and plastic surgery; Ophthalmic +10 moreChester, NYNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.2245304Contract sterilizerOrthopedic; General and plastic surgery; Dental +9 moreWhippany, NJNot verifiedOct 21, 2026
LYOPHILIZATION SERVICES OF NEW ENGLAND, INC.1225991Contract manufacturerCardiovascular; General and plastic surgery; Neurology +1 moreManchester, NHNot verifiedOct 21, 2026
POLY-MED, INC.3020659113Contract manufacturerNeurology; General and plastic surgeryPiedmont, SCNot verifiedOct 21, 2026
STERI-TEK3012448339Contract sterilizerGeneral and plastic surgery; Cardiovascular; Ear, nose and throat +8 moreFremont, CANot verifiedOct 21, 2026
STERITECH, INC.2650143Contract sterilizerGeneral and plastic surgery; Orthopedic; General hospital +6 moreSalinas, PRNot verifiedOct 21, 2026
Sterigenics U.S., LLC1319639Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +14 moreQueensbury, NYNot verifiedOct 21, 2026

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