PuraPly™ Wound Matrix

GUDID 00618474000022

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: 00618474000022
• NIH Device Record Key: 925e6a0d-7f50-45ed-9f3f-daf015046549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly™ Wound Matrix
• Version Model Number: 1
• 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
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx

Device Dimensions

• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square 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
• 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	00618474000022 [Previous]
GS1	00618474000077 [Primary]

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: 2015-05-22

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