FDA.reportPublic FDA data

Sklar

Primary DI
10649111007699
Brand
Sklar
Company
SKLAR CORPORATION
Model
49-2140
Device description
BERNARD FACEBOW PLIER W/CUTTER
Published
2019-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HZXSILVER NITRATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HZXSilver NitrateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111007699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911100769910649111007699

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
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
08800037521163Perfix™ Spinal SystemCG MedTech Co.,Ltd.HZX2019-10-25
10649111104084SklarSKLAR CORPORATIONHZX2019-08-02
10649111042515SklarSKLAR CORPORATIONHZX2019-04-30
10649111043123SklarSKLAR CORPORATIONHZX2019-04-30
10649111043864SklarSKLAR CORPORATIONHZX2019-04-30
10649111044694SklarSKLAR CORPORATIONHZX2019-04-30
10649111045479SklarSKLAR CORPORATIONHZX2019-04-30
10649111048012SklarSKLAR CORPORATIONHZX2019-04-30
10649111048975SklarSKLAR CORPORATIONHZX2019-04-30
10649111049828SklarSKLAR CORPORATIONHZX2019-04-30
10649111050510SklarSKLAR CORPORATIONHZX2019-04-30
10649111052293SklarSKLAR CORPORATIONHZX2019-04-30
10649111054389SklarSKLAR CORPORATIONHZX2019-04-30
10649111055539SklarSKLAR CORPORATIONHZX2019-04-30
10649111056482SklarSKLAR CORPORATIONHZX2019-04-30
10649111111310SklarSKLAR CORPORATIONHZX2019-04-26
10649111113833SklarSKLAR CORPORATIONHZX2019-04-26
10649111103919SklarSKLAR CORPORATIONHZX2019-04-17