FDA.reportPublic FDA data

Sklar

Primary DI
10649111268441
Brand
Sklar
Company
SKLAR CORPORATION
Model
65-3431
Device description
MICRO EAR HK ANG45 DW .6MM 6 INCHES
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JYLHOOK, MICROSURGICAL EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111268441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911126844110649111268441

GMDN Terms#

Term, Definition table
TermDefinition
Eye muscle hookA hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. 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
G043615080BEARBear-Ent, LLCJYL2026-01-19
G043615090BEARBear-Ent, LLCJYL2026-01-19
G043615100BEARBear-Ent, LLCJYL2026-01-19
09348811108364INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
09348811149886INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
04250676734891MENTIO disposable ear curette cottonSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250676734907MENTIO Disposable Nasal SpeculaSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250381821503Gillies skin hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676710017HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676711625ForkSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676705259Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676705266Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716071Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716088Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676738394HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676735560Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735577Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735584Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735591Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735607Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739582Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739599Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739605Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739612Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739629Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676745248Universal scissorsSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
00757770406265Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770406371Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770410125Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770412631Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05