FDA.reportPublic FDA data

Sklar

Primary DI
10649111397882
Brand
Sklar
Company
SKLAR CORPORATION
Model
98-7810C
Device description
CENSITRAC READY MICRO SCIS STR SHP 6 IN FLT HNDL
Published
2019-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10649111397882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911139788210649111397882

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
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
00810189450998Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451018Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451032Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451056Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451070Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451513Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451568Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451728Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451735Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810220800317Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800331Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800355Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800362Adler Instrument CompanyAdler, Inc.LRW2026-06-02
09348811115461INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-06-02
00810143908329SURGIPROSSurgipros, LLCLRW2026-06-01
00810212930688SURGIPROSSurgipros, LLCLRW2026-06-01
B356BK211110American MedicalsAmerican MedicalsLRW2026-05-29
00846159039702SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039719SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039726SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039733SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039740SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039757SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27