PuraPly™ Wound Matrix

GUDID 00618474000152

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: 00618474000152
• NIH Device Record Key: f52d68a8-4465-46a0-881f-0f76acc234a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly™ Wound Matrix
• Version Model Number: 515-024
• 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: 2.05 Centimeter
• Length: 2.05 Centimeter
• Length: 2.05 Centimeter
• Length: 2.05 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	00618474000145 [Primary]
GS1	00618474000152 [Package]; Contains: 00618474000145; Package: Case [4 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: 2017-05-12

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