AccessGUDID - DEVICE: Microlyte AG (B519910010)

GUDID

Device Identifier (DI) Information

Brand Name: Microlyte AG
Version or Model: 91001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 91001
Company Name: IMBED BIOSCIENCES, INC.

Primary DI Number: B519910010
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 962084500 *Terms of Use

Device Description: Gelling fiber wound dressing, 2" x 2"

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):	Yes
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 Humidity: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 4 Square inch

Device Record Status

Public Device Record Key: b427d3e3-153c-44b4-b4f7-9025833265ce
Public Version Date: July 19, 2024
Public Version Number: 8
DI Record Publish Date: February 01, 2017