Phoenix Wound Matrix

GUDID 20852513007090

NANOFIBER SOLUTIONS, INC.

Synthetic nanofiber barrier dressing

• Primary Device ID: 20852513007090
• NIH Device Record Key: da309c84-a943-4b7d-a526-5989f78ba4f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phoenix Wound Matrix
• Version Model Number: FG-0014
• Company DUNS: 830384223
• Company Name: NANOFIBER SOLUTIONS, 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852513007096 [Primary]
GS1	10852513007093 [Package]; Contains: 00852513007096; Package: Shelf Box [1 Units]; In Commercial Distribution
GS1	20852513007090 [Package]; Contains: 10852513007093; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173544

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-08-22

On-Brand Devices [Phoenix Wound Matrix]

• 00852513007041: FG-0004
• 00852513007034: FG-0003
• 00852513007027: FG-0002
• 00852513007010: FG-0001
• 20852513007090: FG-0014
• 20852513007083: FG-0013
• 20852513007076: FG-0006
• 20852513007069: FG-0005