FDA.reportPublic FDA data

SILVEX

Primary DI
00020424270063
Brand
SILVEX
Company
TOTAL RESOURCES INTERNATIONAL INC.
Model
04HBC21061
Device description
Silver Wound Wash, 4 Fl. Oz.
Published
2023-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K151185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151185000AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)Abl Medical, LLC2016-02-05FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00020424270063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00020424270063000204242700630204242700630020424270063

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 Volume4Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18887717824info@trikits.com

Regulatory Flags#

DUNS number
790160535
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
00020424221249BE SMART GET PREPARED22EME06124CC; 22EME06124CCPLTQTR2026-04-21
20020424226811BE SMART GET PREPARED22EME06081NEWPLT2026-04-02
00020424010157BE SMART GET PREPARED20HBC01015REV5X004BQ2VVL2026-03-31
00020424016432ESSENTIALS16LOW0164312504542026-03-27
00020424100087Be Smart Get Prepared10COM15008REV12025-11-24
00020424060770BE SMART GET PREPARED22EME06077; 22EME06077A2025-11-21
00020424201159BE SMART GET PREPARED20HBC01015CCREV3; 20HBC01015CCREV4; 20HBC01015REV4X0013DSLAP2024-01-09
00020424220815BE SMART GET PREPARED22EME06081NEWCC2025-03-05
00781002848950L.H. Dottie16DOT01405CS2025-02-25
00020424210083BE SMART GET PREPARED03HBC21073PK82025-01-24
00020424101824BE SMART GET PREPARED10HBC01082REV1A2025-01-10
00020424150075BE SMART GET PREPARED10COM15007REV22025-01-10
00020424014025Be Smart Get Prepared10HBC014022025-01-09
00020424211745Be Smart Get Prepared03HBC211742025-01-09
00020424211851Be Smart Get Prepared03HBC211852025-01-09
00020424060879BE SMART GET PREPARED22EME06087REV1; 22EME06087REV22024-01-05
00020424013639BE SMART GET PREPARED10COM01363; 10HBC01363; 10HBC01363RECOMX0044NVFNL2024-01-12
00020424021429BE SMART GET PREPARED10OUT02142; 10OUT02142REV12024-01-05
00020424080013BE SMART GET PREPARED00-GAU-8001YOU00-GAU-8001YOU2024-12-13
00020424199975Be Smart Get Prepared19-NAS-04997CS2024-12-10

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