FDA.reportPublic FDA data

MPM SilverMed

Primary DI
00366977141031
Brand
MPM SilverMed
Company
Mpm Medical, LLC
Model
3
Catalog number
ABSM1410
Device description
MPM SilverMed Antimicrobial Hydrogel 3 oz Tube. Packaged 12 tubes per case
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K073019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073019000SILVERMED ANTIMICROBIAL SILVER HYDROGELArgentis Biomedical Incorporated2008-09-16FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366977141031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366977141031003669771410313669771410310366977141031

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002325512Info@mpmmed.com

Regulatory Flags#

DUNS number
081241522
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366977333337ACM Surgical Collagen1MP003332022-12-07
00366977010252CoMatryx Surgical Bovine Type 1 Collagen 2.5mL1COM102022-12-07
00366977020053CoMatryx Surgical Bovine Type 1 Collagen2COM202022-12-07
00366977020503MetaMatrix Surgical Bovine Type 1 Collagen2META202022-12-07
00366977102506MetaMatrix Surgical Bovine Type 1 Collagen2META102022-12-07
00366977310222MPM Triple Helix Collagen Drsg 2X21MP003102022-12-07
00366977311014Triple Helix Collagen Powder6MP003112022-12-07
00366977312127"MPM Triple Helix Collagen Wound Drsg 12"" Rope"1MP003122022-12-07
00366977314442MPM Triple Helix Collagen Dressing 4x41MP003142022-12-07
00366977315012MPM Triple Helix Collagen Powder2mp003152022-12-07
00366977329828ACM Surgical Collagen1MP003292022-12-07
00366977334457ACM Surgical Extra Advanced Collagen2MP003342022-12-07
00366977337779ACM Surgical Extra Collagen2MP003372022-12-07
00366977345019ACM Surgical Collagen2MP003452022-12-07
00366977377775MPM Medical2MP003772022-12-07
00366977140454MPM SilverMed Antimicrobial Hydrogel2ABSM14042022-12-07
00366977141581MPM SilverMed3ABSM14152022-12-07
00366977206334MPM CoolMagic3MP002062022-12-07
00366977208680MPM Cool Magic6MP002082022-12-07
00366977140157MPM SilverMed Antimicrobial Hydrogel3ABSM14062022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29