FDA.reportPublic FDA data

Sklar®

Primary DI
10649111343797
Brand
Sklar®
Company
SKLAR CORPORATION
Model
06-1627
Device description
"SPRAGUE RAPPAPORT STETH 28""BK"
Published
2018-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LDESTETHOSCOPE, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDEStethoscope, ManualCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111343797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911134379710649111343797

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical external stethoscopeA non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
10649111183386Sklar40-73122019-09-24
10649111183560Sklar40-73132019-09-24
10649111183713Sklar40-73142019-09-24
10649111183881Sklar40-73152019-09-24
10649111183997Sklar40-73162019-09-24
10649111184260Sklar40-73172019-09-24
10649111184420Sklar40-73182019-09-24
10649111187896Sklar40-73402019-09-24
10649111087431Sklar Instruments96-01922025-11-12
10649111225369Sklar Instruments96-10922025-11-12
10649111226281Sklar Instruments96-10972025-11-12
10649111226458Sklar Instruments96-10982025-11-12
10649111226762Sklar Instruments96-11002025-11-12
10649111226984Sklar Instruments96-11022025-11-12
10649111227370Sklar Instruments96-11052025-11-12
10649111228056Sklar Instruments96-11102025-11-12
10649111228919Sklar Instruments96-11152025-11-12
10649111229817Sklar Instruments96-11202025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536933507BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933514BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933521BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933538BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933569BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933576BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933583BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933590BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933606BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00197998470479Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470493Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470516Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470530Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470554Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470578Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00010939960184Foster & ThriveMCKESSON CORPORATIONLDE2024-06-18
00193489016416MedlineMEDLINE INDUSTRIES, INC.LDE2024-03-05
00057475506490BIOS DiagnosticsThermor LtdLDE2023-06-05
00057475507497BIOS DiagnosticsThermor LtdLDE2023-06-05
00057475508494BIOS DiagnosticsThermor LtdLDE2023-06-05
50080196171482MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
50080196716249MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
50080196779190MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
10885380067969CARDINAL HEALTHCardinal Health 200, LLCLDE2022-12-08
10885380067976CARDINAL HEALTHCardinal Health 200, LLCLDE2022-12-08
10885380067983CARDINAL HEALTHCardinal Health 200, LLCLDE2022-12-08
10653160278801CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLDE2022-01-02
10653160291510CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLDE2022-01-02
M3687111001LABTRONGF HEALTH PRODUCTS, INC.LDE2021-08-24
10885632287459MedichoiceOWENS & MINOR DISTRIBUTION, INC.LDE2020-12-14