FDA.report

3M™ Tegaderm™

Primary DI
04064035036751
Brand
3M™ Tegaderm™
Company
3M COMPANY
Model
90612
Catalog number
90612
Device description
3M™ Tegaderm™ High Performance Foam Adhesive Dressing 90612, Square, 10 Bag/Carton, 4 Carton/Case
Published
2022-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04064035036751PackageGS11In Commercial Distribution
04064035036768PackageGS11In Commercial Distribution
04064035036744PrimaryGS10
04064035036737Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04064035036751040640350367514064035036751
04064035036768040640350367684064035036768
04064035036744040640350367444064035036744
04064035036737040640350367374064035036737

GMDN Terms

TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
830016148
Device count
10
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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