Microlyte PainGuard

GUDID 00850019162387

Microlyte PainGuard, 10cm x 10cm

IMBED BIOSCIENCES, INC.

Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Primary Device ID00850019162387
NIH Device Record Key3e4190ae-c7ba-4462-90ae-f8539a3d60c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrolyte PainGuard
Version Model NumberMLPG1010
Company DUNS962084500
Company NameIMBED BIOSCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com
Phone888-472-9898
Emailcs@imbedbio.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019162387 [Primary]

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-29
Device Publish Date2025-08-21

On-Brand Devices [Microlyte PainGuard]

00850019162387Microlyte PainGuard, 10cm x 10cm
00850019162370Microlyte PainGuard, 5cm x 5cm
00850019162363Microlyte PainGuard, 3cm x 3cm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.