PuraPly Antimicrobial Wound Matrix

GUDID 00618474000312

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

ORGANOGENESIS INC.

Animal-derived wound matrix dressing

• Primary Device ID: 00618474000312
• NIH Device Record Key: b1d05ae5-47f7-4896-99a3-9100ab916c28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly Antimicrobial Wound Matrix
• Version Model Number: 515-048
• 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: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 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	00618474000312 [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 Wound Matrix]

• 00618474000329: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that
• 00618474000312: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that
• 00618474000305: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that
• 00618474000299: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that
• 00618474000190: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that
• 00618474000183: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that
• 00618474000176: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that
• 00618474000169: PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that