FDA.reportPublic FDA data

3M™ Tegaderm™

Primary DI
50707387446494
Brand
3M™ Tegaderm™
Company
3M COMPANY
Model
90120
Catalog number
90120
Device description
3M(TM) Tegaderm(TM) High Integrity Alginate Rope 90120
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387446494PackageGS14In Commercial Distribution
08711428064674PrimaryGS10
00707387446499Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738744649450707387446494
08711428064674087114280646748711428064674
00707387446499007073874464997073874464990707387446499

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-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; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, 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
830016148
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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

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