FDA.reportPublic FDA data

3M™ Silvercel™

Primary DI
25032749039415
Brand
3M™ Silvercel™
Company
3M Deutschland GmbH
Model
900202
Catalog number
900202
Device description
3M™ Silvercel™ Non-Adherent Antimicrobial Alginate Dressing, 900202, 2 in x 2 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
35032749039412PackageGS15In Commercial Distribution
25032749039415PrimaryGS10
15032749039418Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3503274903941235032749039412
2503274903941525032749039415
1503274903941815032749039418

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

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Primary DI, Brand, Model table
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507073878180623M™ Tegaderm™1685NS1685NS2026-05-08
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007073874969683M™CMW06CMW062026-05-08
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007073874969993M™CMW02CMW022026-05-08
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040545967359103M™ Impregum™P31779P317792026-05-08

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Primary DI, Brand, Company table
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