FDA.reportPublic FDA data

Sklar

Primary DI
10649111455216
Brand
Sklar
Company
SKLAR CORPORATION
Model
90-6275
Device description
RHEINSTAEDTER CUR BLUNT 14MM
Published
2019-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10649111455216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911145521610649111455216

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
DM exempt
false
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956419832CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-23
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50198956389852CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-02
50198956331509CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-23
50198956377156CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-23
50198956326857CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-17
50198956340679CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-13
50198956344646CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-13
50198956326635CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-09
50198956329513CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-09
50198956311907CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-30
50198956291926CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-26
50198956317428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-26
50198956141665CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-07
50198956267587CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-07
50198956289589CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-05
50198956289329CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-29
50198956302240CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-26
50198956268225CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-22
50198956325249CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-22
50198956290080CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-19
04046826068424MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHCY2025-12-17
50198956252675CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-17
50198956215465CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-11
50198956281248CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-11
50198956210811CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-09
50198956263985CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-09
50198956140637CARDINAL HEALTHCardinal Health 200, LLCHCY2025-11-25
50198956253528CARDINAL HEALTHCardinal Health 200, LLCHCY2025-11-25