FDA.reportPublic FDA data

Sklar Instruments

Primary DI
50649111492899
Brand
Sklar Instruments
Company
SKLAR CORPORATION
Model
96-4113
Device description
ECONO STERILE SIMS UTERINE CURETTE #3 STER25
Published
2025-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCYCURETTE, UTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50649111492899PackageGS125In Commercial Distribution
10649111492891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5064911149289950649111492899
1064911149289110649111492891

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, manualA heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10198956475366CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-05
10198956366428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
10198956476530CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
07898506815111QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815135QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815159QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815319QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815333QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815340QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815357QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815364QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506840922QuinelatoSchobell Industrial LtdaHCY2023-01-09
10195594752279CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-26
10195594758813CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-25
10195594745776CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-18
10195594754730CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-15
10195594684549CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594758981CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594750367CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-12
10195594685485CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-08
10195594735142CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-07
10195594727260CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594727314CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594740702CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594745981CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594623807CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-24
10195594715830CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594717186CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594727680CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594730994CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23