PuraPly™ Antimicrobial Wound Matrix

GUDID 00618474000121

PuraPly™ Antimicrobial Wound Matrix 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 pouches.

ORGANOGENESIS INC.

Collagen wound matrix dressing

• Primary Device ID: 00618474000121
• NIH Device Record Key: 783c8a02-6d7f-4a08-8d6c-3eab18a66877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly™ Antimicrobial Wound Matrix
• Version Model Number: 515-020
• 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: true
• 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

Customer Support Contacts

• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx

Device Dimensions

• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000121 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-11-16

On-Brand Devices [PuraPly™ Antimicrobial Wound Matrix]

• 00618474000121: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
• 00618474000114: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
• 00618474000107: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
• 00618474000091: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
• 00618474000084: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
• 00618474000039: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
• 00618474000435: PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethyleneb
• 00618474000459: PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethyleneb
• 00618474000442: uraPly™ Antimicrobial Wound Matrix (fenestrated) consists of a collagen sheet coated with poly