Microlyte AG 91001

GUDID B519910012

Gelling fiber wound dressing, 2" x 2"

IMBED BIOSCIENCES, INC

Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

Primary Device ID	B519910012
NIH Device Record Key	b427d3e3-153c-44b4-b4f7-9025833265ce
Commercial Distribution Status	In Commercial Distribution
Brand Name	Microlyte AG
Version Model Number	91001
Catalog Number	91001
Company DUNS	962084500
Company Name	IMBED BIOSCIENCES, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	true

Device Dimensions

Area/Surface Area	4 Square inch
Area/Surface Area	4 Square inch
Area/Surface Area	4 Square inch
Area/Surface Area	4 Square inch
Area/Surface Area	4 Square inch
Area/Surface Area	4 Square inch
Area/Surface Area	4 Square inch

Operating and Storage Conditions

Storage Environment Humidity	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B519910010 [Primary]
HIBCC	B519910011 [Package] Contains: B519910010 Package: Box [5 Units] In Commercial Distribution
HIBCC	B519910012 [Package] Contains: B519910011 Package: Carton [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153756

FDA Product Code

FRO	Dressing, Wound, Drug

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-02-01

On-Brand Devices [Microlyte AG]

B519910022	Gelling fiber wound dressing, 4"x4"
B519910012	Gelling fiber wound dressing, 2" x 2"