PuraPly™ Antimicrobial XT Wound Matrix

GUDID 00061874000282

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.

ORGANOGENESIS INC.

Collagen dressing

• Primary Device ID: 00061874000282
• NIH Device Record Key: 957307f5-f02a-4cac-9b49-8d2b674d8839
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly™ Antimicrobial XT Wound Matrix
• Version Model Number: 515-036
• 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

Customer Support Contacts

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

Device Dimensions

• Length: 6 Centimeter

Operating and Storage Conditions

• 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	00061874000282 [Primary]

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: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [PuraPly™ Antimicrobial XT Wound Matrix ]

• 00618474000275: PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam
• 00061874000282: PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam
• 00618474000282: PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam
• 00618474000466: PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam