MicroLyte Ag

Basic Information

• Brand Name: MicroLyte Ag
• Primary DI: B519910020
• Version / Model: 91002
• Catalog Number: 91002
• Company Name: IMBED BIOSCIENCES, INC.
• Labeler DUNS: 962084500
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-01
• Public Version: 8
• Public Version Date: 2024-07-19
• Public Version Status: Update
• Public Device Record Key: c7219c44-c20d-45a7-9412-c9555f2a2e48
• Distribution End Date: 2019-12-31

Device Description

Gelling fiber wound dressing, 4"x4"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B519910022	HIBCC	Carton	5	Not in Commercial Distribution	2019-12-31
Package	B519910021	HIBCC	Box	5	Not in Commercial Distribution	2019-12-31
Primary	B519910020	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153756	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	16	Square inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius