AccessGUDID - DEVICE: MIRRAGEN® Advanced Wound Matrix (B477MWM0106EA0)

GUDID

Device Identifier (DI) Information

Brand Name: MIRRAGEN® Advanced Wound Matrix
Version or Model: MWM-0106
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ETS Wound Care LLC

Primary DI Number: B477MWM0106EA0
Issuing Agency: HIBCC
Commercial Distribution End Date: August 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080578874 *Terms of Use

Device Description: Resorbable Borate Glass Wound Management Device

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?
64853	Synthetic wound matrix dressing	A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QSZ	Absorbable Synthetic Wound Dressing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161067	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c5d8f66-72ac-4761-a526-476db137f972
Public Version Date: February 03, 2025
Public Version Number: 9
DI Record Publish Date: February 14, 2020