FDA.reportPublic FDA data

Sklar®

Primary DI
10649111238055
Brand
Sklar®
Company
SKLAR CORPORATION
Model
41-1305
Device description
"JOSEPH BUTTON END KNIFE ANG 6"""
Published
2019-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KASKNIFE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KASKnife, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111238055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911123805510649111238055

GMDN Terms#

Term, Definition table
TermDefinition
Nasal knifeA hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal 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
09348811143594INKAThe Trustee for KAISER FAMILY TRUSTKAS2026-03-18
09348811155153INKAThe Trustee for KAISER FAMILY TRUSTKAS2025-11-28
00810207783169Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783176Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783183Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783190Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783206Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783213Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783220Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783237Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783244Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783251Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00190776414238MillenniumAvalign Technologies, Inc.KAS2025-10-22
00194613047528MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2025-08-01
04049047120292GimmiGimmi GmbHKAS2025-05-21
04049047120339GimmiGimmi GmbHKAS2025-05-21
04049047120360GimmiGimmi GmbHKAS2025-05-21
04049047120407GimmiGimmi GmbHKAS2025-05-21
00194613100285MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2025-03-21
00194613089689MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2024-08-15
00194613090821MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2024-08-15
00840306812361Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
00840306812378Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
00840306812385Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
G586E97860210Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
G586E97860220Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
G586E97860230Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
00190776046965AvalignAvalign Technologies, Inc.KAS2023-11-13
00190776046972AvalignAvalign Technologies, Inc.KAS2023-09-28
00190776224776AvalignAvalign Technologies, Inc.KAS2023-09-28