FDA.reportPublic FDA data

GynoVision

Primary DI
06946332802148
Brand
GynoVision
Company
Chongqing Jinshan Science & Technology (Group) Co., Ltd
Model
JSX-T-6
Device description
Disposable Hysteroscopic Cannula, 1 pack
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
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
06946332802148PackageGS110Not in Commercial Distribution
06946332802155PackageGS110Not in Commercial Distribution
06946332802131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946332802148069463328021486946332802148
06946332802155069463328021556946332802155
06946332802131069463328021316946332802131

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
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06946332802117GynoVisionJSX-12020-09-01
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
06946332802117GynoVisionChongqing 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