FDA.reportPublic FDA data

Sklar®

Primary DI
10649111111655
Brand
Sklar®
Company
SKLAR CORPORATION
Model
64-1152
Device description
"ENUCLEATION SCISS FULL CRV 5"""
Published
2018-03-02
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
10649111111655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911111165510649111111655

GMDN Terms#

Term, Definition table
TermDefinition
Enucleation scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut tissue during surgery involving enucleation of the eye and/or its related structures (i.e., the removal of the eyeball to, e.g., remove a malignant tumour or to relieve intolerable pain in a blind eye). 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 made of high-grade stainless steel and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. 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
10649111347993Sklar10-15482019-05-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426651MillenniumAvalign Technologies, Inc.LRW2026-08-19
04054462913541evonosevonos GmbH & Co. KGLRW2026-08-19
04054462913572evonosevonos GmbH & Co. KGLRW2026-08-19
04054462913589evonosevonos GmbH & Co. KGLRW2026-08-19
00190776426392MillenniumAvalign Technologies, Inc.LRW2026-08-18
00198506094149ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
00198506094156ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
00198506094163ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
04054462903252evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903269evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903276evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903283evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903306evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903320evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903337evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903344evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903351evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903368evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903375evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903382evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903399evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904648evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904662evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904686evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904693evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904709evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904716evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904730evonosevonos GmbH & Co. KGLRW2026-08-18
04054462907908evonosevonos GmbH & Co. KGLRW2026-08-18
04054462908271evonosevonos GmbH & Co. KGLRW2026-08-18