FDA.reportPublic FDA data

Gynex

Primary DI
00850003294834
Brand
Gynex
Company
JOSNOE MEDICAL, INC.
Model
GYN SE8200
Device description
Insufflation Set Smoke Evacutor
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCZTube, Smoke Removal, Endoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCZTube, Smoke Removal, EndoscopicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003294827PackageGS112In Commercial Distribution
00850003294834PackageGS14In Commercial Distribution
00850003294841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003294827008500032948278500032948270850003294827
00850003294834008500032948348500032948340850003294834
00850003294841008500032948418500032948410850003294841

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965627859
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003294841GynexGYN SE82002024-11-08
00850003294070JosNoe Medical IncPFITF-102019-09-11
00850003294193JosNoe Medical IncTM-60002019-10-31
00850003294346JosNoe Medical IncSP-1042019-10-31
00850003294407JosNoe Medical IncJNM-OC84S2019-11-05
00850003294445JosNoe Medical IncJNM-OC84S-RTP2019-11-05
00850003294476JosNoe Medical IncHS-1002019-11-05
00850003294513JosNoe Medical IncHF-7001S2019-11-05
00850003294506JosNoe Medical IncHS-100-NSM-502019-11-05
00850003294254JosNoe Medical IncJNM-1222-NSM-502019-10-31
00850003294261JosNoe Medical IncTM-6000-NSM-502019-10-31
00850003294308JosNoe Medical IncSP-1022019-10-31
00850003294339JosNoe Medical IncSP-102-NSM-502019-10-31
00850003294155JosNoe Medical IncJNM-12222019-10-28
00850003294223JosNoe Medical IncITF10-NSM-502019-10-02
00850003294377JosNoe Medical IncJNM-02032019-11-05
00850003294278JosNoe Medical IncJNM-2000162019-11-05
00850003294285JosNoe Medical IncJNM-2000162019-11-05
00850003294384JosNoe Medical IncJNM-02032019-11-05
00850003294421JosNoe Medical IncJNM-OC84S2019-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060768280576SESISSURGEASE INNOVATIONS LIMITEDFCZ2026-05-09
00850003294841GynexJOSNOE MEDICAL, INC.FCZ2024-11-08
04714127863184blue endoUNIMAX MEDICAL SYSTEMS INC.FCZ2024-06-20
14714127863181blue endoUNIMAX MEDICAL SYSTEMS INC.FCZ2024-06-20
00840306828393Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828409Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828416Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828423Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828430Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306822780Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822797Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822803Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822810Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822827Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822841Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822858Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822896Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822759Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
00840306822766Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
GYNX80091GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80241GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80721GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81001GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81031GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX82001GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80090GynexGYNEX CORPORATIONFCZ2023-12-19