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

Pessary, Vaginal (HHW) (10)

Premarket Exempt

Clear

MedGyn Pessary Cerclage w/o drain # 3 - M803050193 Catalog Number : 050193

Device Description : Pessary Cerclage is used to treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage#4 w/o drain - M803050194 Catalog Number : 050194

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage w/o drain #5 - M803050195 Catalog Number : 050195

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage # 6 w/o drain - M803050196 Catalog Number : 050196

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Silicone Donut # 7 - M803050199 Catalog Number : 050199

Device Description : Pessary Silicone donut is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage # 1 w/drain - M803050210 Catalog Number : 050210

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage # 2 w/drain - M803050211 Catalog Number : 050211

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage # 3 w/drain - M803050212 Catalog Number : 050212

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage # 4 w/drain - M803050213 Catalog Number : 050213

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

MedGyn Pessary Cerclage # 5 w/drain - M803050214 Catalog Number : 050214

Device Description : Pessary Cerclage is used treat uterine prolapse.

Device Class : 2

Duns Number: 103913430

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

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