FDA.reportPublic FDA data

Sklar

Primary DI
10649111217586
Brand
Sklar
Company
SKLAR CORPORATION
Model
70-9303
Device description
COAKLEY CURETTE SIZE 3 6 3/4 INCHES
Published
2019-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZSCURETTE, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111217586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911121758610649111217586

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus curetteA slender, hand-held, manual surgical instrument designed for scraping and/or excising tissue from one of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary). The distal end of the instrument is finished in an appropriate shape (e.g., cup-, ring-, spoon-like) according to the procedure to be performed; the device is typically made of high-grade stainless steel and is available in a variety of shapes and sizes. 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
07640139342119ROMEO 2 INSTRUMENTATIONSpineArt SAFZS2025-11-10
10649111094002SklarSKLAR CORPORATIONFZS2019-08-26
10649111094088SklarSKLAR CORPORATIONFZS2019-08-26
10649111217210SklarSKLAR CORPORATIONFZS2019-03-15
10649111217494SklarSKLAR CORPORATIONFZS2019-03-15
10649111217838SklarSKLAR CORPORATIONFZS2019-03-15
10649111217944SklarSKLAR CORPORATIONFZS2019-03-15
10649111218071SklarSKLAR CORPORATIONFZS2019-03-15
10649111271793SklarSKLAR CORPORATIONFZS2019-03-15
10649111272240SklarSKLAR CORPORATIONFZS2019-03-15
10649111272707SklarSKLAR CORPORATIONFZS2019-03-15
10649111273827SklarSKLAR CORPORATIONFZS2019-03-15
10649111273995SklarSKLAR CORPORATIONFZS2019-03-15
10649111274176SklarSKLAR CORPORATIONFZS2019-03-15
10649111275241SklarSKLAR CORPORATIONFZS2019-03-15
10649111275371SklarSKLAR CORPORATIONFZS2019-03-15
10649111275500SklarSKLAR CORPORATIONFZS2019-03-15
10649111275975SklarSKLAR CORPORATIONFZS2019-03-15
10649111278266SklarSKLAR CORPORATIONFZS2019-03-15
10649111278426SklarSKLAR CORPORATIONFZS2019-03-15
10649111278594SklarSKLAR CORPORATIONFZS2019-03-15
10649111278747SklarSKLAR CORPORATIONFZS2019-03-15
10649111017711SklarSKLAR CORPORATIONFZS2019-03-13
10649111017858SklarSKLAR CORPORATIONFZS2019-03-13
10649111018084SklarSKLAR CORPORATIONFZS2019-03-13
10649111018282SklarSKLAR CORPORATIONFZS2019-03-13
10649111018619SklarSKLAR CORPORATIONFZS2019-03-13
10649111161612SklarSKLAR CORPORATIONFZS2019-03-13
10649111161964SklarSKLAR CORPORATIONFZS2019-03-13
10649111162060SklarSKLAR CORPORATIONFZS2019-03-13