FDA.reportPublic FDA data

Sklar®

Primary DI
10649111069208
Brand
Sklar®
Company
SKLAR CORPORATION
Model
64-3430
Device description
"KNAPP IRIS SCISS STR S/B 4"""
Published
2018-01-24
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
10649111069208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911106920810649111069208

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.

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
00190776395575MillenniumAvalign Technologies, Inc.LRW2026-07-14
00190776395582MillenniumAvalign Technologies, Inc.LRW2026-07-14
04059453162618Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-07-13
00850088713022PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713060PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713077PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713084PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713091PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
B382SD9032161000Surgical DirectSurgical Direct, Inc.LRW2026-07-10
B382SD90390213SC0Surgical DirectSurgical Direct, Inc.LRW2026-07-10
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