FDA.reportPublic FDA data

Silvakollagen Gel

Primary DI
00860008336200
Brand
Silvakollagen Gel
Company
The Hymed Group Corporation
Model
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
2023-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132891000HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVERThe Hymed Group Corp.2014-06-19FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008336217PackageGS16In Commercial Distribution
00860008336200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008336217008600083362178600083362170860008336217
00860008336200008600083362008600083362000860008336200

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-337-6296customerservice@dermarite.com

Regulatory Flags#

DUNS number
926634791
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008336217Silvakollagen Gel 005002023-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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