FDA.reportPublic FDA data

Solventum™ Steri-Strip™

Primary DI
00197998347061
Brand
Solventum™ Steri-Strip™
Company
Solventum US LLC
Model
R1547SB
Catalog number
R1547SB
Device description
Solventum™ Steri-Strip™ Reinforced Skin Closures, R1547SB, Sterile, 1/2in x 4 in (12 mm x 100 mm), 6 Strip/Envelope, Bulk
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
00197998347078PackageGS1500In Commercial Distribution
00197998347061PrimaryGS10
00197998347054Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998347078001979983470781979983470780197998347078
00197998347061001979983470611979983470610197998347061
00197998347054001979983470541979983470540197998347054

Contacts#

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

Regulatory Flags#

DUNS number
119004140
Device count
6
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
00197998346880Solventum™ Steri-Strip™R1546R15462026-10-31
00197998346965Solventum™ Steri-Strip™R1549R15492026-10-31

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
00197998346880Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998346965Solventum™ Steri-Strip™Solventum US LLCKGX2026-10-31
00197998347030Solventum™ 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