FDA.reportPublic FDA data

Sklar®

Primary DI
40649111224196
Brand
Sklar®
Company
SKLAR CORPORATION
Model
96-1085
Device description
STER LLETZ LOOP ELEC 20X20 BX5
Published
2017-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HGIELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40649111224196PrimaryGS10
06491112241964Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4064911122419640649111224196
06491112241964064911122419646491112241964

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
5
Lot or batch
true
Serial number
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
00887482177044BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177082BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482141656BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177075BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177570BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177594BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177723BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177754BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177792BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177839BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177877BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177914BovieSYMMETRY SURGICAL INC.HGI2024-08-27
10887482177928BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
00887482177952BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177976BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177990BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178010BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178034BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178058BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178072BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178133BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178171BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178218BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178232BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178256BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178270BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178294BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178317BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178331BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178355BovieSYMMETRY SURGICAL INC.HGI2024-08-27