Phoenix Wound Matrix

GUDID 00852513007010

NANOFIBER SOLUTIONS, INC.

Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing

• Primary Device ID: 00852513007010
• NIH Device Record Key: 332b7e7b-34a4-4fde-a914-92308aa1cb2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phoenix Wound Matrix
• Version Model Number: FG-0001
• 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

• Length: 8 Inch
• Length: 8 Inch
• Width: 4 Inch
• Length: 8 Inch
• Width: 4 Inch
• Length: 8 Inch
• Width: 4 Inch
• Length: 8 Inch
• Width: 4 Inch
• Length: 8 Inch
• Width: 4 Inch
• Length: 8 Inch
• Width: 4 Inch
• Length: 8 Inch
• Width: 4 Inch
• Length: 8 Inch

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	00852513007010 [Primary]
GS1	10852513007017 [Package]; Package: Shelf Box [5 Units]; Discontinued: 2019-08-22; Not in Commercial Distribution
GS1	20852513007014 [Package]; Contains: 10852513007017; Package: Case [8 Units]; Discontinued: 2019-08-22; Not in Commercial Distribution
GS1	30852513007011 [Package]; Package: Shelf Box [1 Units]; In Commercial Distribution
GS1	40852513007018 [Package]; Contains: 30852513007011; 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: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-09-11

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