FDA.reportPublic FDA data

MedGyn Flexible/Karman Cannula-Curette 10mm

Primary DI
M803K022010
Brand
MedGyn Flexible/Karman Cannula-Curette 10mm
Company
MEDGYN PRODUCTS, INC.
Model
10mm Flexible/Karman Curette
Catalog number
022010K
Device description
10mm Flexible/Karman Curette
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
M803K022010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home-use peritoneal dialysis connection kit housingA component of a peritoneal dialysis connection kit intended to function as a casing for elements used in a routine connection/disconnection between a peritoneal catheter and a dialysate line. It is a portable, closable, rigid housing with user interface levers/buttons designed to be manually manipulated to provide a mechanical connection/disconnection between the elements inside (e.g., premounted catheter adaptor, proximal end of the dialysate line), previously fitted in the housing by the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103913430
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M803010466MedGyn Video ColposcopeAL-106HD010466HD2016-09-08
M803003276512Uterine ManipulatorUterine Manipulator/ InjectorTMI11512026-06-08
M803003276515Uterine ManipulatorUterine Manipulator/ InjectorTMI11512026-06-08
M8030030134Baby Tischler Biopsy Punch Titanium"Baby Tischler Biopsy Punch Titanium 10"" (254mm) 0301342025-11-16
M8030030139Tischler Biopsy Punch Titanium"Tischler Biopsy Punch Titanium 8 1/2"" (216mm) - 0301392025-11-16
M803029801Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Up"0298012025-11-16
M803029802Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Down"0298022025-11-16
M803029803Tischler Biopsy Punch"Tischler Biopsy Punch 10"" (254mm) Left"0298032025-11-16
M803029804Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Right"0298042025-11-16
M803029811Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Up "0298112025-11-16
M803029812Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Down"0298122025-11-16
M803029813Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10"" (254mm) Left"0298132025-11-16
M803029814Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Right"0298142025-11-16
M803030101Tischler Biopsy Punch"Tischler Biopsy Punch 81/2"" (216mm)"0301012025-11-16
M80303010110"Tischler Biopsy Punch 10"" (254mm)""Tischler Biopsy Punch 10"" (254mm)"030101102025-11-16
M803030102Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 81/2"" (216mm)"0301022025-11-16
M80303010210Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10""(254mm)"030102102025-11-16
M803030103Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 81/2"" (216mm)"0301032025-11-16
M80303010310Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 10"" (254mm)"030103102025-11-16
M803030104Rotating Tischler Biopsy PunchRotating Tischler Biopsy Punch0301042025-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395636MillenniumAvalign Technologies, Inc.HCY2026-07-14
10198956388789CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-06
00850083275464Intrace USAPILOTIS TECH LLCHCY2026-07-03
00850083275488Intrace USAPILOTIS TECH LLCHCY2026-07-03
00198506091537ELMED INCORPORATEDELMED INCORPORATEDHCY2026-06-10
00198506091544ELMED INCORPORATEDELMED INCORPORATEDHCY2026-06-10
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
10195594745776CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-18
10195594684549CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
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
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