PuraPly Micronized Wound Matrix (PuraPly MZ)

GUDID 00618474000398

PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.

ORGANOGENESIS INC.

Collagen wound matrix dressing

• Primary Device ID: 00618474000398
• NIH Device Record Key: fa5b6931-91c9-4f24-8318-04bcc6d4b322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraPly Micronized Wound Matrix (PuraPly MZ)
• Version Model Number: 515-059
• 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: true
• 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

• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram
• Weight: 100 Milligram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or expose to excess heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220317

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2023-05-09
• Device Publish Date: 2023-05-01

On-Brand Devices [PuraPly Micronized Wound Matrix (PuraPly MZ) ]

• 00618474000411: PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intende
• 00618474000404: PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intende
• 00618474000398: PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intende