MedtechSourcebook

Hemostatic Metal Clip For The Gi Tract (PKL) contract manufacturers

6 US facilities list FDA product code PKL as a contract manufacturer (3) or contract sterilizer (3).

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

FDA device name
Hemostatic Metal Clip For The Gi Tract
Product code
PKL (FDA product classification database)
Device class
Class II
Regulation
21 CFR 876.4400
Classification panel
Gastroenterology and urology
FDA flags
implant, life-sustaining or life-supporting

Where they are

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

All 6 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
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
ROBLING MEDICAL, LLC3007829657Contract manufacturerGeneral and plastic surgery; General hospital; Gastroenterology and urology +6 moreYoungsville, NCNot verifiedOct 21, 2026
Sage Product Development, Inc.3014328942Contract manufacturerGastroenterology and urology; General and plastic surgery; Ear, nose and throat +3 moreFoxborough, MANot verifiedOct 21, 2026

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