AccessGUDID - DEVICE: Microlyte Matrix (00850019162110)

GUDID

Device Identifier (DI) Information

Brand Name: Microlyte Matrix
Version or Model: ML1010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMBED BIOSCIENCES, INC.

Primary DI Number: 00850019162110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962084500 *Terms of Use

Device Description: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.

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:	Yes
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?
48073	Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag)]. It is intended to protect and facilitate healing of minor cuts, scrapes, abrasions, lacerations, blisters, and scalds by absorbing wound exudates while creating a moist wound-healing environment and reducing microbial colonization within the dressing. The device is typically in the form of a flat sheet/film and is intended for use in the home or a clinical setting. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153756	000

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: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 100 Square centimeter

Device Record Status

Public Device Record Key: 3ec5a3eb-40af-4be1-b6b0-97dba1133fca
Public Version Date: July 19, 2024
Public Version Number: 4
DI Record Publish Date: February 02, 2023