MicroLyte Ag 91002

GUDID B519910022

Gelling fiber wound dressing, 4"x4"

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	B519910022
NIH Device Record Key	c7219c44-c20d-45a7-9412-c9555f2a2e48
Commercial Distribution Status	In Commercial Distribution
Brand Name	MicroLyte Ag
Version Model Number	91002
Catalog Number	91002
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	false
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	16 Square inch
Area/Surface Area	16 Square inch
Area/Surface Area	16 Square inch
Area/Surface Area	16 Square inch
Area/Surface Area	16 Square inch
Area/Surface Area	16 Square inch
Area/Surface Area	16 Square inch

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	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	B519910020 [Primary]
HIBCC	B519910021 [Package] Contains: B519910020 Package: Box [5 Units] In Commercial Distribution
HIBCC	B519910022 [Package] Contains: B519910021 Package: Carton [5 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	2017-10-01

On-Brand Devices [MicroLyte Ag]

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