FDA.reportPublic FDA data

3M™ Silvercel™

Primary DI
25032749039422
Brand
3M™ Silvercel™
Company
3M Deutschland GmbH
Model
900404
Catalog number
900404
Device description
3M™ Silvercel™ Non-Adherent Antimicrobial Alginate Dressing, 900404, 4-1/4 in x 4-1/4 in, 10/Ct, 5 Cts/Cs
Published
2023-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K081363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081363000NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSINGAdvanced Medical Solutions Limited2008-09-24FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35032749039429PackageGS15In Commercial Distribution
25032749039422PrimaryGS10
15032749039425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3503274903942935032749039429
2503274903942225032749039422
1503274903942515032749039425

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
315731711
Device count
10
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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040640351931953M™ Tegaderm™1624W1624W2026-07-24
040640351932323M™ Tegaderm™1626W1626W2026-07-24
307073877737323M™ Coban™2094N2094N2026-05-08
307073877737493M™ Coban™2794N2794N2026-05-08
340467190223813M™ Coban™209420942026-05-08
507073878180243M™ Tegaderm™1624WNS1624WNS2026-05-08
507073878180313M™ Tegaderm™1626WNS1626WNS2026-05-08
507073878180483M™ Tegaderm™1628NS1628NS2026-05-08
507073878180553M™ Tegaderm™1688NS1688NS2026-05-08
507073878180623M™ Tegaderm™1685NS1685NS2026-05-08
507073878180793M™ Tegaderm™1683NS1683NS2026-05-08
007073874969683M™CMW06CMW062026-05-08
007073874969753M™CMW04CMW042026-05-08
007073874969823M™CMW03CMW032026-05-08
007073874969993M™CMW02CMW022026-05-08
007073878101223M™ Micropore™1530SS-11530SS-12026-05-08
040467192917003M™ Coban™2794E2794E2026-05-08
040545960049553M™ Coban™209220922026-05-08
040545966458133M™71507715072026-05-08

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Primary DI, Brand, Company table
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00850087488723CeeportCEEPORT INC.FRO2026-08-26
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00850087488853CeeportCEEPORT INC.FRO2026-08-26
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04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
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00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
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