Solventum US LLC EX-1123833

GUDID 00197998465239

Solventum™ EX-1123833 Matrix

Solventum US LLC

Dental matrix band, single-use
Primary Device ID00197998465239
NIH Device Record Keye07183a1-c03a-48ac-9da1-54d3c173def6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolventum US LLC
Version Model NumberEX-1123833
Catalog NumberEX-1123833
Company DUNS119004140
Company NameSolventum US LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197998465239 [Primary]

FDA Product Code

KCQTUBE IMPRESSION AND MATRIX

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-08
Device Publish Date2025-06-30

Devices Manufactured by Solventum US LLC

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00197998470523 - Littmann® Classic III™2026-02-11 Littmann® Classic III™ Stethoscope, 5623C, Stainless-finishChestpiece, Satin-finish Caribbean Blue Tube
00197998470547 - Littmann® Cardiology IV™2026-02-11 Littmann® Cardiology IV™ Stethoscope, 6177C, Mirror Chestpiece,Satin-finish Black Tube
00197998470561 - Littmann® Cardiology IV™2026-02-11 Littmann® Cardiology IV™ Stethoscope, 6242C, High Polish RainbowChestpiece, Satin-finish Navy Tube
00197998470585 - Littmann® Cardiology IV™2026-02-11 Littmann® Cardiology IV™ Stethoscope, 6159C, Stainless-finishChestpiece, Satin-finish Rose Pink Tube
00197998154973 - Solventum™ Bair Hugger™2026-02-09 Solventum™ Bair Hugger™ Warming Gown, 81001, Standard, 30/CS
00197998154997 - Solventum™ Bair Hugger™2026-02-09 Solventum™ Bair Hugger™ Warming Gown with Booties, 83001, Standard, 30/CS

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