FDA.reportPublic FDA data

Sklar

Primary DI
50649111448773
Brand
Sklar
Company
SKLAR CORPORATION
Model
96-2277M
Device description
BUCK EAR CUR STR BLSIZE 2STRLCS/25
Published
2019-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50649111448773PrimaryGS10
00649111448778Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5064911144877350649111448773
00649111448778006491114487786491114487780649111448778

GMDN Terms#

Term, Definition table
TermDefinition
Endaural curette, single-useA slender, hand-held, manual surgical instrument designed for scraping within the ear canal (e.g., removing wax), and for procedures during middle ear surgery (e.g., removal of the superior bony rim). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
25
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
09348811100559INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100566INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100573INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100818INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100849INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100856INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
20888277660196MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660233MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660240MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-05
00612479269538McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269569McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269590McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269620McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269651McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269682McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00194613018269MSI Precision Specialty InstrumentsMed Saver, Inc.JYG2024-08-15
08904461000321OSSEOUS Rosen InserterEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319620OSSEOUS Jobson Horne Probe-RoundEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319637OSSEOUS Jobson Horne Probe-OvalEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319644OSSEOUS Cerumen hookEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319668OSSEOUS Myringotomy knifeEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
20888277660202MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660219MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660226MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660257MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277669168MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20193489141495MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141501MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141518MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141525MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18