KESSEL medintim GmbH

Address:Kelsterbacher Str. 28,Morfelden-Walldorf Hesse,DE

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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

Device, External Penile Rigidity (LKY) (8) Diaphragm, Contraceptive (And Accessories) (HDW) (1)

Premarket Exempt

No Yes

Clear

Active Erection System - 04013273000116 Catalog Number :

Device Description : Vacuum Erection Device for treatment of erectile dysfunction

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Constriction Ring 9mm - 04013273000208 Catalog Number : Ring 1

Device Description : Constriction ring or pubic ring to be use together with a vacuump pump for trea Constriction ring or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Constriction Ring 12mm - 04013273000215 Catalog Number : Ring 2

Device Description : Constriction ring in 12mm or pubic ring to be use together with a vacuump pump f Constriction ring in 12mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Constriction Ring 15mm - 04013273000222 Catalog Number : Ring 3

Device Description : Constriction ring in 15mm or pubic ring to be use together with a vacuump pump f Constriction ring in 15mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Constriction Ring 18mm - 04013273000239 Catalog Number : Ring 4

Device Description : Constriction ring in 18mm or pubic ring to be use together with a vacuump pump f Constriction ring in 18mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Constriction Ring 21mm - 04013273000246 Catalog Number : Ring 5

Device Description : Constriction ring in 21mm or pubic ring to be use together with a vacuump pump f Constriction ring in 21mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Manual Erection System - 04013273001175 Catalog Number : MES 01

Device Description : Vacuum Erection Device for treatment of erectile dysfunction for impotence due t Vacuum Erection Device for treatment of erectile dysfunction for impotence due to: Diabetes, Protata surgery, elevated blood lipids, vascular diseases, smoking, excessive alcohol

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Caya contoured diaphragm - 04013273001649 Catalog Number : DIA CAYA USA

Device Description : Caya Silicone Vaginal Diaphragm for contraception

Device Class : 2

Duns Number: 537500365

Premarket Exempt : No

Product Code : HDW

Prescription Use : Yes

Device Count : 1

Active3 Erection System - 04013273001915 Catalog Number : AES 3

Device Description : Vaccum Erection Device for treatment of erectily dysfunction

Device Class : 2

Duns Number: 537500365

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

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