FDA.report

3M™ Tegaderm™

Primary DI
04064035036799
Brand
3M™ Tegaderm™
Company
3M COMPANY
Model
90611
Catalog number
90611
Device description
3M™ Tegaderm™ High Performance Foam Adhesive Dressing 90611, Small Oval, 10 BG/CTN 4 CTN/CS
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
04064035036799PackageGS11In Commercial Distribution
04064035036805PackageGS11In Commercial Distribution
04064035036782PrimaryGS10
04064035036775Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04064035036799040640350367994064035036799
04064035036805040640350368054064035036805
04064035036782040640350367824064035036782
04064035036775040640350367754064035036775

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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