FDA.reportPublic FDA data

GynoVision

Primary DI
06946332802117
Brand
GynoVision
Company
Chongqing Jinshan Science & Technology (Group) Co., Ltd
Model
JSX-1
Device description
Image recorder, 1 pack
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGHCannula, Suction, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGHCannula, Suction, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172151000Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd.2018-04-09HGH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946332802117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946332802117069463328021176946332802117

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video hysteroscopeAn electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8602386098151Service@jinshangroup.com

Regulatory Flags#

DUNS number
545245755
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946332803725BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PARTPUMP-12022-02-22
06946332804173alpHaONEJSPC-12023-01-23
06946332804203alpHaONEJSPR-32023-01-23
06946332800649alpHaONEJSPR-32021-07-01
06946332800045alpHaONEJSPC-12021-07-01
06946332803701BEAMER AVEO IRRIGATION PUMP BOTTLE HOLDER (US/EU) REPLACEMENT PARTPUMP-32022-02-22
06946332803718BEAMER AVEO IRRIGATION PUMP BOTTLE HOLDER (US/EU) REPLACEMENT PARTPUMP-32022-02-22
06946332803732BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PARTPUMP-12022-02-22
06946332803749BEAMER AVEO IRRIGATION PUMP HEAD REPLACEMENT PARTPUMP-22022-02-22
06946332803145Beamer AVEO™ Irrigation PumpAVEOPUMP2021-12-31
06946332800625alpHaONEJSPC-12021-07-01
06946332802131GynoVisionJSX-T-62020-09-01
06946332802193GynoVisionJSX-T-72020-09-01
06946332802254GynoVisionJSX-T-82020-09-01
06946332802148GynoVisionJSX-T-62020-09-01
06946332802209GynoVisionJSX-T-72020-09-01
06946332802261GynoVisionJSX-T-82020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946332802131GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802193GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802254GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802148GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802209GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802261GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
04715309124758NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124765NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124772NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124789NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124802NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124819NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124826NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124833NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124840NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124857NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124864NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124871NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124888NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125274NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125281NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125298NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125304NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124796NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125328NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125335NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125342NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125359NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125366NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125373NAPANPAC MEDICAL CORPORATIONHGH2017-05-10