FDA.reportPublic FDA data

SilvaKollagen Gel

Primary DI
01714196500150
Brand
SilvaKollagen Gel
Company
Sion Brands LLC
Model
00500
Catalog number
00500
Device description
Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial cuts, lacerations, abrasions, irritations of the skin. RX for partial and full thickness wounds. Store at controlled room temperature. Silver oxide controls the growth of microbes that are absorbed into the wound gel. https://dermarite.com/product/silvakollagen-gel/
Published
2023-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

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
00714196500151PackageGS16In Commercial Distribution
01714196500150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196500151007141965001517141965001510714196500151
01714196500150017141965001501714196500150

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118753405
Device count
1
Lot or batch
true
Expiration date on label
true

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