FDA.reportPublic FDA data

MedGyn MGC-200 Cryotherapy System

Primary DI
M803019000
Brand
MedGyn MGC-200 Cryotherapy System
Company
MEDGYN PRODUCTS, INC.
Model
unit, cryosurgical, accessories
Catalog number
019000
Device description
unit, cryosurgical, accessories
Published
2024-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M803019000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103913430
Device count
1
Serial number
true
Manufacturing 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
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28