FDA.reportPublic FDA data

Sklar®

Primary DI
40649111009540
Brand
Sklar®
Company
SKLAR CORPORATION
Model
21-107
Device description
IRIS SCISS CVD S/S 3.5" BX12
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
40649111009540PrimaryGS10
00649111009542Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064911100954040649111009540
00649111009542006491110095426491110095420649111009542

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
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
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
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055250547Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256211Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256235Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256242Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256259Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258604Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258611Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258628Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258635Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258642Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258659Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258666Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258673Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258680Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258697Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258703Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258710Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258727Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810220800218Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810220800225Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810220800232Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810055250455Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250462Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250479Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250486Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250493Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250509Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250516Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250523Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250554Surgical DesignSurgical Design, Inc.LRW2026-05-25