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

Curette, Uterine (HCY) (7) Dilator, Cervical, Hygroscopic-Laminaria (HDY) (3)

Premarket Exempt

Clear

MedGyn Laminaria - M803021024 Catalog Number : 021024

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 - M803021025 Catalog Number : 021025

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 - M803021026 Catalog Number : 021026

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 Uterine Curette - M803022004 Catalog Number : 022004

Device Description : 16mm rigid straight curette

Device Class : 1

Duns Number: 103913430

Premarket Exempt : No

Product Code : HCY

Prescription Use : Yes

Device Count : 1

MedGyn Uterine Curette - M803022005 Catalog Number : 022005

Device Description : 5mm flexible curette

Device Class : 1

Duns Number: 103913430

Premarket Exempt : No

Product Code : HCY

Prescription Use : Yes

Device Count : 1

MedGyn Uterine Curette - M803022006 Catalog Number : 022006

Device Description : 6mm flexible curette

Device Class : 1

Duns Number: 103913430

Premarket Exempt : No

Product Code : HCY

Prescription Use : Yes

Device Count : 1

MedGyn Uterine Curette - M803022007 Catalog Number : 022007

Device Description : 7mm flexible curette

Device Class : 1

Duns Number: 103913430

Premarket Exempt : No

Product Code : HCY

Prescription Use : Yes

Device Count : 1

MedGyn Uterine Curette - M803022008 Catalog Number : 022008

Device Description : 8mm flexible curette

Device Class : 1

Duns Number: 103913430

Premarket Exempt : No

Product Code : HCY

Prescription Use : Yes

Device Count : 1

MedGyn Uterine Curette - M803022009 Catalog Number : 022009

Device Description : 9mm flexible curette

Device Class : 1

Duns Number: 103913430

Premarket Exempt : No

Product Code : HCY

Prescription Use : Yes

Device Count : 1

MedGyn Uterine Curette - M803022010 Catalog Number : 022010

Device Description : 10mm flexible curette

Device Class : 1

Duns Number: 103913430

Premarket Exempt : No

Product Code : HCY

Prescription Use : Yes

Device Count : 1

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