FDA.reportPublic FDA data

Silverstream

Primary DI
07290016506075
Brand
Silverstream
Company
SilverStream Medical Ltd.
Model
SS-1000-01
Catalog number
SS-1000-01
Device description
SilverStream wound management and moisturizing solution 250ml
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
27290016506079PackageGS112In Commercial Distribution
07290016506075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729001650607927290016506079
07290016506075072900165060757290016506075

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 Volume250Milliliter

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
07290016506068Silverstream SS-1000-02SS-1000-022023-11-29
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
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000187VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26