PuraPly™ Antimicrobial XT Wound Matrix

PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™…

Registry build 21.09.26

PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.

3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KMF
Manufacturer City Province Registered as Device types
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Shenzhen JPY ION-Tech. Co., Ltd. Shenzhen Guangdong Contract manufacturer 20

Record

Regulatory record for PuraPly™ Antimicrobial XT Wound Matrix
Listed by Organogenesis Inc., United States
FDA product code KMF
Device type Bandage, Liquid
Device class Class 1
Regulation 21 CFR 880.5090
Establishment Complaint-file establishment, Manufacturer
Record published 2019-10-01
Record revised 2025-07-21 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Special storage condition: Store in a clean, dry location at room temperature; Special storage condition: Do not expose to temperatures above 120 degrees fahrenheit
Sizes Width 5 cm; length 5 cm

Catalogue Numbers

Catalogue numbers for PuraPly™ Antimicrobial XT Wound Matrix
Catalogue number Size Status
515-034 Width 5 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
PolyMem Ferris MFG. Corp. 60
3M™ Cavilon™ 3M Company 54
Kendall Cardinal Health 23
Kendall Cardinal Health 200, LLC 15
Curity Cardinal Health 11
GluSeal® Glustich Inc 7
Stratis Covidien LP 7
Curity Cardinal Health 200, LLC 6
Tritis Covidien LP 4
GluSeal®90 Glustich Inc 3
Medline Medline Industries, Inc. 3
GluSeal®90 Skinstitch Corp. 2

Showing 12 of 29. All products under Bandage, Liquid

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer