FDA.reportPublic FDA data

Sklar®

Primary DI
40649111043186
Brand
Sklar®
Company
SKLAR CORPORATION
Model
21-358
Device description
"LITTAUER STITCH SCISS 5.5""BX12"
Published
2018-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40649111043186PrimaryGS10
00649111043188Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064911104318640649111043186
00649111043188006491110431886491110431880649111043188

GMDN Terms#

Term, Definition table
TermDefinition
Suture scissorsA hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically metallic and is available in various designs and sizes; the blades may have different shapes, e.g., they can be curved or straight with a hook-like tip to capture the suture/ligature as it is cut. It is not a dedicated ophthalmic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
12
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
00850083275006Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275013Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275037Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275044Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275051Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275068Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275266Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275273Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275297Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275303Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275587Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275716Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275907Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275914Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275921Intrace USAPILOTIS TECH LLCLRW2026-07-03
00810055259342Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810055259359Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810055259366Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810055259373Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810158211254PRINCETONPrinceton Medical Group, Inc.LRW2026-06-23
00810158211285PRINCETONPrinceton Medical Group, Inc.LRW2026-06-23
00810055258567Surgical DesignSurgical Design, Inc.LRW2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.LRW2026-06-22
07898789390053KAYE FREEMAN FACE-LIFT SCISSORS CURVED 23CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDALRW2026-06-09
00810055251520Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810055251537Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450714Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450721Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450738Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450752Surgical DesignSurgical Design, Inc.LRW2026-06-06