Wound GelHA Matrix

Primary DI
00358407992511
Brand
Wound GelHA Matrix
Company
Industria Farmacéutica Andrómaco, S.A. de C.V.
Model
One, 1/3 oz. Tube
Device description
"""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. """
Published
2022-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00358407992511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00358407992511003584079925113584079925110358407992511

GMDN Terms#

Term, Definition table
TermDefinition
Skin osmotic dressing, non-antimicrobialA substance (e.g., ointment, cream, spray, impregnated material) intended to be topically applied to the skin (e.g., face, eyelids, extremities) and containing compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to expedite wound healing and skin re-epithelialization primarily through osmotic properties which absorb and retain water to create a moist environment; it does not include antimicrobial agents. It may be used to treat superficial and/or deep wounds (e.g., abrasions, lacerations, burns, surgical wounds, decubitus sores, ulcers). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
810330282
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00358407070011Wound GelHA TMOne, 0.33 oz (9.45g) Tube2022-05-13
00358407992535Wound GelHA MatrixThree - 1/3 oz. Tubes2022-05-13

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Primary DI, Brand, Company table
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