Wound GelHA Matrix

GUDID 00358407992511

"WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA MatrixTM is a combination of emollients and sodium hyaluronate which function to maintain tissue hydration and support the healing process. WoundGelHA MatrixTM has been demonstrated to be of value in the management of certain skin ulcers. Sodium hyaluronate is a salt of hyaluronic acid, a naturally occurring molecule found in various body tissues. The sodium hyaluronate present in WoundGelHA MatrixTM is derived from synthetic sources. "

Industria Farmacéutica Andrómaco, S.A. de C.V.

Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial
Primary Device ID00358407992511
NIH Device Record Keya929e866-3784-44c8-af85-7210be665fc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameWound GelHA Matrix
Version Model NumberOne, 1/3 oz. Tube
Company DUNS810330282
Company NameIndustria Farmacéutica Andrómaco, S.A. de C.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100358407992511 [Primary]

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-13

On-Brand Devices [Wound GelHA Matrix]

00358407992535"WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA Mat
00358407992511"WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA Mat

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.