FDA.reportPublic FDA data

Sklar®

Primary DI
10649111346231
Brand
Sklar®
Company
SKLAR CORPORATION
Model
06-1640
Device description
PEDIATRIC STETH 30" GRAY
Published
2018-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10649111346231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911134623110649111346231

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970784670222Rhino Rescuewenzhou dongfang medical instrument co.,ltdLDE2026-03-24
00197998470486Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470509Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470523Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470547Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470561Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470585Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00767056422018MabisD-M-S HOLDINGS, INC.LDE2025-12-29
06975185470136LightningWenzhou Kangshun Medical Devices CO.,LTDLDE2025-09-15
06975185470150LightningWenzhou Kangshun Medical Devices CO.,LTDLDE2025-09-15
06974546523160TealmedNingbo Tealmed Emergency Products Co., Ltd.LDE2025-07-21
04053755203048GAMMA 3.2Heine Optotechnik GmbH & Co. KGLDE2025-07-17
06974546523153TealmedNingbo Tealmed Emergency Products Co., Ltd.LDE2025-05-12
06975185470037AcmeWenzhou Kangshun Medical Devices CO.,LTDLDE2025-03-05
04030155004819Colorscop-duo stethoscope, pinkKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155004970Standard-Prestige stethoscope stainless steel, blackKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155005076Planet double stethoscope according to FassbenderKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155005168Ear tips, black, Ø 5,5 mm, PU: 10 pcs. W. white turned partsKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155011695Stethoscope double tube, black, length 60cmKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155019448Planet Air stethoscopeKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
10889483005378SunMedSUNMED, LLCLDE2023-08-01
00888277722388MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
00634782600402Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782600990Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601003Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601010Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601027Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601034Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601072Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601089Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11