FDA.report

Gynex

Primary DI
GYNX80090
Brand
Gynex
Company
GYNEX CORPORATION
Model
8009
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FCZTube, Smoke Removal, Endoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
FCZTube, Smoke Removal, EndoscopicGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
GYNX80091PrimaryHIBCC0
GYNX80090Unit of UseHIBCC0

GMDN Terms

TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012997685
Device count
50
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
false
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 DIBrandModelCatalogPublished
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26
GYNX298000Gynex29-8002023-12-26
GYNX298500Gynex29-8502023-12-26
GYNX299000Gynex29-9002023-12-26
GYNX31300Gynex31302023-12-26
GYNX31350Gynex31352023-12-26
GYNX32050Gynex32052023-12-26
GYNX32070Gynex32052023-12-26
GYNXNHL34500GynexNHL34502023-12-26
GYNXNHMH3410140GynexNHMH3410-142023-12-26
GYNXNHMH3410160GynexNHMH3410-162023-12-26
GYNXNHMH3410180GynexNHMH3410-182023-12-26
GYNXNHMH3410200GynexNHMH3410-202023-12-26
GYNXNHW34000GynexNHW34002023-12-26
GYNXS0010GynexS0012023-12-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850003294834GynexJOSNOE MEDICAL, INC.FCZ2024-11-08
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
GYNX80240GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80720GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81000GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81030GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX82000GynexGYNEX CORPORATIONFCZ2023-12-19
20888937015687SeeClear MAX Laparoscopic Smoke Evacuation SystemCoopersurgical, Inc.FCZ2022-11-10
20888937015694SeeClear XcL Laparoscopic Smoke Evacuation SystemCoopersurgical, Inc.FCZ2022-11-10
10851695005576Tech Medical ServicesTECHMEDICAL SERVICES, INC.FCZ2021-06-25
09349967004227Laparoscopic Smoke EvacuatorTHE O R COMPANY PTY LTDFCZ2021-04-12