MEDGYN PRODUCTS, INC.

Address:100 W Industrial Rd,Addison,IL,60101,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

Cannula, Manipulator/Injector, Uterine (LKF) (6)

Premarket Exempt

Clear

HS Catheters - M803TMI1187 Catalog Number : TMI1187

Device Description : Shapeable HS Catheter,7F

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

HS Catheters - M803TMI1188 Catalog Number : TMI1188

Device Description : Steen, open-tip HS Catheter

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

HSG Kits - M803TMI1198 Catalog Number : TMI1198

Device Description : HSG tray with Shapeable 5F HS

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

HSG Kits - M803TMI1199 Catalog Number : TMI1199

Device Description : HSG tray with Shapeable 7F HS

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

HS Catheters - M803TMI20002 Catalog Number : TMI20002

Device Description : Miller advance catheter,28cm

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Uterine Manipulator - M803TMI6003 Catalog Number : TMI6003

Device Description : K-UMI Manipulator

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

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