FDA.reportPublic FDA data

Solventum™ Tegaderm™

Primary DI
00197998415548
Brand
Solventum™ Tegaderm™
Company
Solventum Germany GmbH
Model
90611
Catalog number
90611
Device description
Solventum™ Tegaderm™ High Performance Adhesive Foam Dressing, 90611, Small Oval, 10 BAG/CAR, 4 CAR/CS, 40/CS
Published
2026-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
00197998415555PackageGS14In Commercial Distribution
00197998415548PrimaryGS10
00197998415531Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998415555001979984155551979984155550197998415555
00197998415548001979984155481979984155480197998415548
00197998415531001979984155311979984155310197998415531

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
315518329
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998326615Solventum™ Adaptic™MAD003MAD0032026-08-26
00197998326653Solventum™ Adaptic™MAD042MAD0422026-08-26
00197998367281Solventum™ Adaptic™MAD013MAD0132026-08-26
00197998367359Solventum™ Adaptic™MAD023MAD0232026-08-26
00197998367427Solventum™ Adaptic™MAD062MAD0622026-08-26
00197998152252Solventum™ Tegaderm™90600906002026-08-23
00197998152283Solventum™ Tegaderm™90601906012026-08-23
00197998152313Solventum™ Tegaderm™90602906022026-08-23
00197998152344Solventum™ Tegaderm™90603906032026-08-23
00197998152375Solventum™ Tegaderm™90604906042026-08-23
00197998305801Solventum™ Tegaderm™90817908172026-08-23
00197998305832Solventum™ Tegaderm™90815908152026-08-23
00197998305863Solventum™ Tegaderm™90805908052026-08-23
00197998305894Solventum™ Tegaderm™90803908032026-08-23
00197998305924Solventum™ Tegaderm™90802908022026-08-23
00197998305955Solventum™ Tegaderm™90801908012026-08-23
00197998305986Solventum™ Tegaderm™90800908002026-08-23
00197998415500Solventum™ Tegaderm™90613906132026-08-23
00197998415586Solventum™ Tegaderm™90612906122026-08-23
00197998415623Solventum™ Tegaderm™90614906142026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998326615Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998326653Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367281Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367359Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367427Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998152252Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152283Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152313Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152344Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152375Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305801Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305832Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305863Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305894Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305924Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305955Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305986Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415500Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415586Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415623Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998418976Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419010Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419058Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419829Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
06948909462250GentellShaoxing Haoshide Medical Products Co., Ltd.NAC2026-08-21
06940610127725VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127787VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127848VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127879VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127909VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14