Manual Erection System MES 01

GUDID 04013273001175

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

KESSEL medintim GmbH

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• Primary Device ID: 04013273001175
• NIH Device Record Key: 3735035f-65b9-47a5-924b-98210c1a42d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manual Erection System
• Version Model Number: MES 01
• Catalog Number: MES 01
• Company DUNS: 537500365
• Company Name: KESSEL medintim GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com
• Phone: 8008501657
• Email: bob@hpsrx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04013273001175 [Primary]

FDA Product Code

• LKY: Device, External Penile Rigidity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-29
• Device Publish Date: 2021-11-19

Devices Manufactured by KESSEL medintim GmbH

• 04013273000116 - Active Erection System: 2023-08-15 Vacuum Erection Device for treatment of erectile dysfunction
• 04013273001557 - Vagiwell Dilator 5er Set Premium: 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina
• 04013273001564 - Vaginal Dilator 3er Set small: 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina
• 04013273001571 - Vaginal Dilator 3er Set large: 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina
• 04013273000208 - Constriction Ring 9mm: 2022-08-04 Constriction ring or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction
• 04013273000215 - Constriction Ring 12mm: 2022-08-04 Constriction ring in 12mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction
• 04013273000222 - Constriction Ring 15mm: 2022-08-04 Constriction ring in 15mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction
• 04013273000239 - Constriction Ring 18mm: 2022-08-04 Constriction ring in 18mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction