Surgaflex

GUDID 00850019162202

Surgaflex™ 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. Surgaflex™ 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 ID00850019162202
NIH Device Record Keyb2e1d62d-a99e-4776-8839-5f27aeedc328
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgaflex
Version Model NumberSF0420
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 Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 Square centimeter
Area/Surface Area80 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
GS100850019162202 [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 [Surgaflex]

00850019162202Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of bio
00850019162196Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of bio
00850019162189Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of bio
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