FDA.reportPublic FDA data

Silverstream OTC

Primary DI
07290019690092
Brand
Silverstream OTC
Company
SilverStream Medical Ltd.
Model
SS-1000-02
Catalog number
FBS-01-1-OSS-1000-02
Device description
SilverStream OTC 100ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel properties, for skin wounds and burns management and maintenance of moisture level.
Published
2024-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

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
17290019690099PackageGS124In Commercial Distribution
07290019690092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001969009917290019690099
07290019690092072900196900927290019690092

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

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
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
07290016506068Silverstream SS-1000-02SS-1000-022023-11-29
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
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08