FDA.reportPublic FDA data

3M™ Silvercel™

Primary DI
35032749039443
Brand
3M™ Silvercel™
Company
3M Deutschland GmbH
Model
900112
Catalog number
900112
Device description
3M™ Silvercel™ Non-Adherent Antimicrobial Alginate Dressing, 900112, 1 in x 12 in, Rope, 5/Ct, 5 Cts/Cs
Published
2023-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
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
35032749039443PackageGS15In Commercial Distribution
25032749039446PrimaryGS10
15032749039449Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3503274903944335032749039443
2503274903944625032749039446
1503274903944915032749039449

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315731711
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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040640351931573M™ Tegaderm™1624W1624W2026-07-24
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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