AccessGUDID - DEVICE: Phoenix Wound Matrix (00852513007041)

GUDID

Device Identifier (DI) Information

Brand Name: Phoenix Wound Matrix
Version or Model: FG-0004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NANOFIBER SOLUTIONS, INC.

Primary DI Number: 00852513007041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830384223 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62184	Synthetic nanofiber barrier dressing	A sterile covering made of porous, non-woven, synthetic nanofiber material intended to provide protection and/or promote healing of acute and chronic skin wounds. It is a thin, synthetic polymer (e.g., polycaprolactone) fabric material intended to adhere to the wound (without adhesive) to form a barrier against contamination (e.g., from dirt, water, bacteria) while allowing air to contact the wound; it may be semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) and provides minimal wound exudate absorbency. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 1 Inch
Length: 1 Inch

Device Record Status

Public Device Record Key: 0bc91062-9d79-4ec8-aeb5-fc409056fbcd
Public Version Date: August 09, 2021
Public Version Number: 5
DI Record Publish Date: September 11, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10852513007048	5	00852513007041	2019-09-24	Not in Commercial Distribution	Shelf Box
20852513007045	8	10852513007048	2019-09-24	Not in Commercial Distribution	Case
40852513007049	5	00852513007041		In Commercial Distribution	Case
30852513007042	1	00852513007041		In Commercial Distribution	Shelf Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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