MedtechSourcebook

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt (PTS) contract manufacturers

6 US facilities list FDA product code PTS as a contract manufacturer (2) or contract sterilizer (4).

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

FDA device name
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
Product code
PTS (FDA product classification database)
Device class
Class II
Regulation
21 CFR 876.1500
Classification panel
Gastroenterology and urology

Where they are

Florida 2 · Indiana 1 · Massachusetts 1 · New Jersey 1 · South Carolina 1

All 6 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
COOK INCORPORATED1000393132Contract sterilizerGastroenterology and urology; General and plastic surgery; Cardiovascular +8 moreEllettsville, INNot verifiedOct 21, 2026
ENDO-THERAPEUTICS, INC.1056129Contract manufacturerGastroenterology and urologyClearwater, FLNot verifiedOct 21, 2026
INTERNATIONAL STERILIZATION LABORATORY, LLC1061927Contract sterilizerOrthopedic; General and plastic surgery; Gastroenterology and urology +9 moreGroveland, FLNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.1047843Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Orthopedic +13 moreSpartanburg, SCNot verifiedOct 21, 2026
Isomedix Operations Inc.2246552Contract sterilizerGeneral and plastic surgery; Orthopedic; Gastroenterology and urology +12 moreS Plainfield, NJNot verifiedOct 21, 2026
Primo Medical Group, INC1222928Contract manufacturerOrthopedic; General and plastic surgery; Gastroenterology and urology +6 moreStoughton, MANot verifiedOct 21, 2026

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