FDA.reportPublic FDA data

Silverstream

Primary DI
07290016506068
Brand
Silverstream
Company
SilverStream Medical Ltd.
Model
SS-1000-02
Catalog number
SS-1000-02
Device description
SilverStream wound management and moisturizing solution 100ml
Published
2023-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K093227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093227000SILVERSTREAM AND DERMASEPTEnzysurge , Ltd.2009-12-10FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016506065PackageGS124In Commercial Distribution
07290016506068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001650606517290016506065
07290016506068072900165060687290016506068

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Store at room temp

Contacts#

Phone, Email table
PhoneEmail
+14708633009eyal@silverstreammed.com

Regulatory Flags#

DUNS number
533346805
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019690092Silverstream OTCSS-1000-02FBS-01-1-OSS-1000-022024-05-19
07290019690108Silverstream OTCSS-1000-01FBS-01-1-OSS-1000-012024-05-19
07290019690115Silverstream OTCSS-1000-03FBS-01-1-OSS-1000-032024-05-19
17290019690099Silverstream OTCSS-1000-02FBS-01-1-OSS-1000-022024-05-19
27290019690102Silverstream OTCSS-1000-01FBS-01-1-OSS-1000-012024-05-19
27290019690119Silverstream OTCSS-1000-03FBS-01-1-OSS-1000-032024-05-19
07290016506075Silverstream SS-1000-01SS-1000-012023-11-29
07290016506082Silverstream SS-1000-03SS-1000-032023-11-29
17290016506065Silverstream SS-1000-02SS-1000-022023-11-29
27290016506079Silverstream SS-1000-01SS-1000-012023-11-29
27290016506086Silverstream SS-1000-03SS-1000-032023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22