FDA.reportPublic FDA data

Solventum™ Steri-Strip™

Primary DI
00197998346880
Brand
Solventum™ Steri-Strip™
Company
Solventum US LLC
Model
R1546
Catalog number
R1546
Device description
Solventum™ Steri-Strip™ Reinforced Skin Closures, R1546, 1/4 in x 4 in (6 mm x 100 mm), 50/CAR, 4 CAR/CS, 200/CS
Published
2026-10-31
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

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
00197998346897PackageGS150In Commercial Distribution
00197998346903PackageGS14In Commercial Distribution
00197998346880PrimaryGS10
00197998346873Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998346897001979983468971979983468970197998346897
00197998346903001979983469031979983469030197998346903
00197998346880001979983468801979983468800197998346880
00197998346873001979983468731979983468730197998346873

Contacts#

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

Regulatory Flags#

DUNS number
119004140
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
00197998346842Solventum™ Steri-Strip™R1546NSR1546NS2026-11-02
00197998346927Solventum™ Steri-Strip™R1548R15482026-11-02
00197998347009Solventum™ Steri-Strip™R1541SBR1541SB2026-11-02
00197998347283Solventum™ Steri-Strip™R1542SBR1542SB2026-11-02
00197998001239Solventum™ Tegaderm™1877-21001877-21002026-08-23
00197998001260Solventum™ Tegaderm™1879-21001879-21002026-08-23
00197998001352Solventum™ Tegaderm™166416642026-08-23
00197998149559Solventum™ Ioban™8840EZ8840EZ2026-10-30
00197998149580Solventum™ Ioban™8851EZ8851EZ2026-10-30
00197998149610Solventum™ Ioban™8850EZSB8850EZSB2026-10-30
00197998149634Solventum™ Ioban™8850EZ8850EZ2026-10-30
00197998149665Solventum™ Ioban™8851EZSB8851EZSB2026-10-30
00197998149689Solventum™ Ioban™8840EZSB8840EZSB2026-10-30
00197998346750Solventum™ Steri-Strip™A1847A18472026-10-31
00197998346781Solventum™ Steri-Strip™T1545NST1545NS2026-10-31
00197998346804Solventum™ Steri-Strip™R1548NSR1548NS2026-10-31
00197998346828Solventum™ Steri-Strip™R1547NSR1547NS2026-10-31
00197998346866Solventum™ Steri-Strip™R1541NSR1541NS2026-10-31
00197998346965Solventum™ Steri-Strip™R1549R15492026-10-31
00197998347030Solventum™ Steri-Strip™R1540SBR1540SB2026-10-31

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
00197998288593Solventum™ 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
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