Microlyte Matrix

GUDID 00860001725711

Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.

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 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 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 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 Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Primary Device ID00860001725711
NIH Device Record Key92fbadfa-d4d6-47cc-9326-5c80202e19e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrolyte Matrix
Version Model Number91001
Company DUNS962084500
Company NameIMBED BIOSCIENCES, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com
Phone888-472-9898
Emailsuppport@imbedbio.com

Device Dimensions

Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter

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
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
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
GS100860001725704 [Package]
Package: Box [5 Units]
In Commercial Distribution
GS100860001725711 [Primary]
HIBCCB519910010 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-02-10
Device Publish Date2023-02-02

On-Brand Devices [Microlyte Matrix]

00860001725735Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00860001725711Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00850019162226Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00850019162219Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00850019162172Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00850019162165Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00850019162158Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00850019162110Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
00850019162103Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
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