FDA.reportPublic FDA data

Solventum™ Tegaderm™

Primary DI
00197998288593
Brand
Solventum™ Tegaderm™
Company
Solventum Germany GmbH
Model
16002
Catalog number
16002
Device description
Solventum™ Tegaderm™ Transparent Film Roll, 16002, 5 cm x 10 m, 1/CAR, 4 CAR/CS, 4/CS
Published
2026-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998288609PackageGS14In Commercial Distribution
00197998288593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998288609001979982886091979982886090197998288609
00197998288593001979982885931979982885930197998288593

Contacts#

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

Regulatory Flags#

DUNS number
315518329
Device count
1
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
00197998288517Solventum™ Tegaderm™16006160062026-11-01
00197998288555Solventum™ Tegaderm™16004160042026-11-01
00197998054273Solventum™ Micropore™1530S-21530S-22026-10-23
00197998054327Solventum™ Micropore™1530-1181530-1182026-10-23
00197998054358Solventum™ Micropore™1530S-11530S-12026-10-23
00197998054396Solventum™ Micropore™1530SS-11530SS-12026-10-23
00197998307386Solventum™ Actisorb™ Silver 2206502206502202026-10-22
00197998307423Solventum™ Actisorb™ Silver 2201902201902202026-10-22
00197998307461Solventum™ Actisorb™ Silver 2201052201052202026-10-22
00197998115707Solventum™ Clinpro™67008670082026-10-09
00197998079917Solventum™ Durelon™38236382362026-10-08
00197998079955Solventum™ Durelon™38237382372026-10-08
00197998079962Solventum™ Durelon™38019380192026-10-08
00197998079986Solventum™ Durelon™38216382162026-10-08
00197998079993Solventum™ Durelon™38234382342026-10-08
00197998080005Solventum™ Durelon™38235382352026-10-08
00197998099984Solventum™ RelyX™56660566602026-10-08
00197998226724Solventum™ Protemp™46962469622026-10-08
00197998226731Solventum™ Protemp™46973469732026-10-08
00197998226748Solventum™ Protemp™46964469642026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998346842Solventum™ Steri-Strip™Solventum US LLCKGX2026-11-02
00197998346927Solventum™ Steri-Strip™Solventum US LLCKGX2026-11-02
00197998347009Solventum™ Steri-Strip™Solventum US LLCKGX2026-11-02
00197998347283Solventum™ Steri-Strip™Solventum US LLCKGX2026-11-02
00197998288517Solventum™ Tegaderm™Solventum Germany GmbHKGX2026-11-01
00197998288555Solventum™ Tegaderm™Solventum Germany GmbHKGX2026-11-01
00050428135556CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-31
00197998346750Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998346781Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998346804Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998346828Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998346866Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998346880Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998346965Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347030Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347061Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347092Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347139Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347177Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347214Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347252Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347313Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347351Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347399Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197344205281CURADMEDLINE INDUSTRIES, INC.KGX2026-10-29
00197998041525Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998041556Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998042782Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054129Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054150Solventum™ Micropore™Solventum US LLCKGX2026-10-23