PuraPly Antimicrobial Surgical Wound Matrix

GUDID 00618474000503

PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly Antimicrobial Surgical Wound Matrix is supplied in a dry sheet form. The device is packaged in sterile, sealed single pouches.

ORGANOGENESIS INC.

Animal-derived wound matrix dressing

• Primary Device ID: 00618474000503
• NIH Device Record Key: 42021dd5-f4ba-457b-8ebc-e8d34e392fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly Antimicrobial Surgical Wound Matrix
• Version Model Number: 515-057
• Company DUNS: 152165817
• Company Name: ORGANOGENESIS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter
• Length: 6 Centimeter
• Width: 9 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excessive heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051647

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-20
• Device Publish Date: 2026-03-12

On-Brand Devices [PuraPly Antimicrobial Surgical Wound Matrix]

• 00618474000541: PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffol
• 00618474000534: PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffol
• 00618474000503: PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffol
• 00618474000497: PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffol