Phoenix Wound Matrix - NANOFIBER SOLUTIONS, INC.

Duns Number:830384223

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More Product Details

Catalog Number

-

Brand Name

Phoenix Wound Matrix

Version/Model Number

FG-0003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

eb20deea-79ad-40d9-b6cb-a4faf3d7a92a

Public Version Date

August 09, 2021

Public Version Number

5

DI Record Publish Date

September 11, 2018

Additional Identifiers

Package DI Number

10852513007031

Quantity per Package

5

Contains DI Package

00852513007034

Package Discontinue Date

September 17, 2019

Package Status

Not in Commercial Distribution

Package Type

Shelf Box

"NANOFIBER SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2
U Unclassified 18