FDA.reportPublic FDA data

Silovance

Primary DI
00810042271562
Brand
Silovance
Company
MED WAY INC.
Model
3 Oz.
Device description
Silovance Curavance Nano SIlver Gel Antibacterial Wound Dressing Gel, 3 Oz.
Published
2024-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K092826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092826000ASAP ANTIMICROBIAL SILVER WOUND DRESSING GELAmerican Biotech Labs2009-11-12FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042271562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042271562008100422715628100422715620810042271562

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
Weight85Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8885633929sales@medwayus.com

Regulatory Flags#

DUNS number
112481778
Device count
1
Combination product
true
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
00810042270084MedVanceV30208202025-09-17
00810042270237MedVanceV3010408W2025-09-17
00810042270251MedVanceV3010412W2025-09-17
00810042270558MedVanceV30206082025-09-17
00810042270619MedVanceV3010303-102025-09-17
00810042270626MedVanceV3010202-102025-09-17
00810042270633MedVanceV3010205-102025-09-17
00810042270640MedVanceV3010404-102025-09-17
00810042270657MedVanceV3110707-102025-09-17
00810042270770MedVanceV3010408-102025-09-17
00810042270787MedVanceV3010412-102025-09-17
00810042270794MedVanceV3010606-102025-09-17
00810042271548MedVanceV30106082025-09-17
00857544007015MedVanceV30104042025-09-17
00857544007046MedVanceV30106062025-09-17
00857544007077MedVanceV30102022025-09-17
00857544007107MedVanceV30103032025-09-17
00857544007169MedVanceV31107072025-09-17
00857544007190MedVanceV31109092025-09-17
00857544007497MedVanceV40000122025-09-17

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Primary DI, Brand, Company table
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00197998307461Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
10080196299850MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-10-22
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
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05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
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00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08