PelashieldAM

GUDID 00850019162134

PelashieldAM™ 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. PelashieldAM™ 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 ID00850019162134
NIH Device Record Key528a34d1-1171-4d71-8103-95f134a5fbf5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePelashieldAM
Version Model NumberPS1023
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
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com
Phone888-472-9898
Emailsupport@imbedbio.com

Device Dimensions

Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 Square centimeter
Area/Surface Area230 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
GS100850019162134 [Primary]

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 [PelashieldAM]

00850019162141PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of
00850019162134PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of
00850019162127PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of
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