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

Colposcope (And Colpomicroscope) (HEX) (7) Dilator, Cervical, Hygroscopic-Laminaria (HDY) (3)

Premarket Exempt

Clear

MedGyn Gynescope - M803010198 Catalog Number : 010198

Device Description : MedGyn AL-401 Colposcope with Tilt Stand (3-Step Magnification)

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

MedGyn Gynescope - M803010200 Catalog Number : 010200

Device Description : MedGyn Gynescope (Colposcope)

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

MedGyn Video Colposcope - M803010466 Catalog Number : 010466

Device Description : Video Colposcope

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

medgyn video colposcope - M803010466SA1 Catalog Number : 010466sa

Device Description : Swing Arm Video Colposcope

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

MedGyn Video Colposcope - M803010469 Catalog Number : 010469

Device Description : Video Colposcope

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

MedGyn Gynescope - M803010500 Catalog Number : 010500

Device Description : MedGyn Gynescope (Colposcope)

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

MedGyn Gynescope (Colposcope) - M803010505 Catalog Number : 010505

Device Description : Swing Arm AL-105

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

MedGyn Laminaria - M803021002 Catalog Number : 021002

Device Description : dilator of the uterine cervix

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HDY

Prescription Use : Yes

Device Count : 1

MedGyn Laminaria - M803021003 Catalog Number : 021003

Device Description : Dilator of Uterine Cervix

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HDY

Prescription Use : Yes

Device Count : 1

MedGyn Laminaria - M803021004 Catalog Number : 021004

Device Description : Dilator of uterine cervix

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HDY

Prescription Use : Yes

Device Count : 1

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