FDA.reportPublic FDA data

Sklar®

Primary DI
10649111066283
Brand
Sklar®
Company
SKLAR CORPORATION
Model
67-4604
Device description
"ALEXANDER CHISEL 7"" 4MM"
Published
2018-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111066283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911106628310649111066283

GMDN Terms#

Term, Definition table
TermDefinition
Mastoid chiselA single-bladed, surgical instrument, bevelled on one side with a flat cutting edge that is used to cut and shape the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically a one-piece instrument made of high-grade stainless steel. 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
04054896001753ChiselSilony Medical GmbHFZO2026-09-18
04054896001760ChiselSilony Medical GmbHFZO2026-09-18
04054896001777ChiselSilony Medical GmbHFZO2026-09-18
04054896005751ChiselSilony Medical GmbHFZO2026-09-18
04054896018430ChiselSilony Medical GmbHFZO2026-09-18
04054896018447ChiselSilony Medical GmbHFZO2026-09-18
04054896050652ChiselSilony Medical GmbHFZO2026-09-18
04054896050669ChiselSilony Medical GmbHFZO2026-09-18
04054896050676ChiselSilony Medical GmbHFZO2026-09-18
04054896050683ChiselSilony Medical GmbHFZO2026-09-18
04054896050690ChiselSilony Medical GmbHFZO2026-09-18
04054896050706ChiselSilony Medical GmbHFZO2026-09-18
04054896051284ChiselSilony Medical GmbHFZO2026-09-18
04054462907663evonosevonos GmbH & Co. KGFZO2026-08-21
04054462912162evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912179evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912803evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912810evonosevonos GmbH & Co. KGFZO2026-08-19
04054462905416evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905423evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905430evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905447evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905461evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905478evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905485evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905492evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905508evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905515evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905522evonosevonos GmbH & Co. KGFZO2026-08-18
04054462907632evonosevonos GmbH & Co. KGFZO2026-08-18