FDA.reportPublic FDA data

Sklar®

Primary DI
30649111373200
Brand
Sklar®
Company
SKLAR CORPORATION
Model
85-1075
Device description
VAN BUREN SOUND ST/12
Published
2018-11-07
Public version status
New
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
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30649111373200PrimaryGS10
00649111373209Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911137320030649111373200
00649111373209006491113732096491113732090649111373209

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
12
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
true

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
00194613046514MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613100438MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613100766MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613103057MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613103552MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613104238MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613104993MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613105587MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613106614MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613106942MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115913MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115920MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115937MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00190776394189MillenniumAvalign Technologies, Inc.FBX2025-05-07
00190776394196MillenniumAvalign Technologies, Inc.FBX2025-05-07
00840183530037BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530044BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530051BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530068BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530075BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530082BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530099BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530020BR Surgical, LLCBR Surgical, LLCFBX2025-04-15
00840183529789BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00840183529864BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00194613046507MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613100773MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613103545MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613104221MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613105006MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21