PuraPly™ Wound Matrix

GUDID 00618474000053

PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.

ORGANOGENESIS INC.

Collagen wound matrix dressing

• Primary Device ID: 00618474000053
• NIH Device Record Key: 8889da13-277d-4628-9d14-d63f2b6a7bed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly™ Wound Matrix
• Version Model Number: 515-010
• 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
• Phone: 1-888-432-5232
• Email: xx@xx.xx

Device Dimensions

• Length: 2 Centimeter
• Length: 2 Centimeter
• Length: 2 Centimeter
• Length: 2 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000053 [Primary]
GS1	00618474000138 [Package]; Package: Market Unit Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011026

FDA Product Code

• KGN: Dressing, Wound, Collagen

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: 2016-03-24

On-Brand Devices [PuraPly™ Wound Matrix ]

• 00618474000152: PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for th
• 00618474000022: PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for th
• 00618474000060: PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for th
• 00618474000053: PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for th