FDA.reportPublic FDA data

Sklar

Primary DI
30649111143988
Brand
Sklar
Company
SKLAR CORPORATION
Model
67-7605
Device description
TUNING FORK SET OF 5
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30649111143988PrimaryGS10
00649111143987Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911114398830649111143988
00649111143987006491111439876491111439870649111143987

GMDN Terms#

Term, Definition table
TermDefinition
Urostomy kitA collection of non-sterile devices intended to be used for attachment/replacement of a urostomy bag (for collecting urine following a urostomy procedure). It includes the urostomy bag, a base plate, and additional devices (e.g., towels, wipes, scissors) to allow for fitting of the bag/base plate to the patient and hygienic maintenance of the ostomy site (e.g., following leakage). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
5
Premarket exempt
true
Lot or batch
true
Serial number
true
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
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
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
00810005667227TrigonNVision Biomedical Technologies, Inc.MDM2025-12-19
00810135963169ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963183ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963251ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963275ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135962865TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962889TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962896TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962902TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962919TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962926TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962933TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135963435TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810005668040Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963046Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963053Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963060Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963077Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963084Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963091Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963107Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135962650TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27
00810135962667TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27