GYNEX CORPORATION

GYNEX CORPORATION

Address:6631 Browning Dr,North Richland Hills,TX,76180,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrocautery, Gynecologic (And Accessories) (HGI) (9) Cannula, Manipulator/Injector, Uterine (LKF) (1)

Premarket Exempt

No Yes

Clear

Century Uterine Manipulator - GYNX101601 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : LKF

Prescription Use : No

Device Count : 12

Electrode Extender - GYNX1200001 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1205051 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1210071 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1210101 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1210231 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1215051 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1215081 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1215121 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

Radius Loop Electrodes - GYNX1215151 Catalog Number :

Device Class :

Duns Number: 012997685

Premarket Exempt : No

Product Code : HGI

Prescription Use : No

Device Count : 5

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