FDA.reportPublic FDA data

Tegaderm™

Primary DI
50707387565317
Brand
Tegaderm™
Company
3M COMPANY
Model
90501
Catalog number
90501
Device description
90501 TEGADERM SILVER NONWOVEN DRESSING, 4X5IN 5EA/BX, 4 BX/CS
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K053256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0532560003M TEGADERM SILVER (AG) MESH3M Company2005-12-16FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387565317PackageGS14In Commercial Distribution
30707387565313PrimaryGS10
00707387565312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738756531750707387565317
3070738756531330707387565313
00707387565312007073875653127073875653120707387565312

GMDN Terms#

Term, Definition table
TermDefinition
Biochemically-interactive dressing, antimicrobialA sterile, wound-covering substance or material (e.g., ointment, collagen matrix) intended to actively promote the healing of a wound through the temporary modification of a local biochemical parameter(s) or process(es) [e.g., a change to wound pH, enzymatic activity, or protein binding activity], that contains an antimicrobial agent [e.g., silver (Ag), honey]. The device may be used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, or surgical wounds. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830016148
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088877192573983M™186018602016-08-03
088877192574043M™1860S1860S2016-08-03
506380604335343M™ Aura™1870+1870+2022-06-02
000511312755393M™186018602016-08-03
000511312755463M™1860S1860S2016-08-03
00051131498556VFlex™180518052016-08-03
00051131498563VFlex™1805S1805S2016-08-03
00051131499966Aura™1870+1870+2016-08-03
000680608569683M186018602024-10-25
000680608581223M1860S1860S2024-10-25
006380604309583M™ Aura™1870+1870+2021-08-26
006380604313443M™ Aura™1870+BULK1870+BULK2020-10-22
006380604335463M™ Aura™1870+1870+2022-06-02
007073874194243M™186018602016-08-03
007073874441293M™1860S1860S2016-08-03
300511312759293M™ Vflex™180418042018-02-21
300511312759363M™ Vflex™1804S1804S2018-02-21
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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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