FDA.reportPublic FDA data

Sklar®

Primary DI
10649111126642
Brand
Sklar®
Company
SKLAR CORPORATION
Model
64-1240
Device description
"RIBBON STRABIS SCISS STR 4"""
Published
2018-07-24
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
10649111126642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911112664210649111126642

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic strabismus scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut the muscles of the eye during strabismus surgery. It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. It is not intended for intraocular surgery. 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
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00850083275051Intrace USAPILOTIS TECH LLCLRW2026-07-03
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00850083275266Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275273Intrace USAPILOTIS TECH LLCLRW2026-07-03
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00850083275914Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275921Intrace USAPILOTIS TECH LLCLRW2026-07-03
07898789390053KAYE FREEMAN FACE-LIFT SCISSORS CURVED 23CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDALRW2026-06-09
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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