FDA.reportPublic FDA data

SILVEX

Primary DI
00020424210946
Brand
SILVEX
Company
TOTAL RESOURCES INTERNATIONAL INC.
Model
03HBC21094
Device description
Silvex Wound Dressing Gel, 0.5 oz (14g)
Published
2023-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K140483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140483000ASAP OTC WOUND DRESSING GELAbl Medical, LLC2014-05-20FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00020424210946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00020424210946000204242109460204242109460020424210946

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight14Gram

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

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10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
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10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
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10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
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