Vagiwell Dilator 5er Set Premium Vagiwell P

GUDID 04013273001557

Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina, lichen sclerosus

KESSEL medintim GmbH

Vaginal dilator

• Primary Device ID: 04013273001557
• NIH Device Record Key: 64243a15-4067-456f-9975-a7b02fc61934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vagiwell Dilator 5er Set Premium
• Version Model Number: Vagiwell P
• Catalog Number: Vagiwell P
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de
• Phone: +496105203720
• Email: export@medintim.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04013273001557 [Primary]

FDA Product Code

• HDQ: Dilator, Cervical, Fixed Size

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: 2023-07-28
• Device Publish Date: 2023-07-20

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: 2023-07-28Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina, lichen sclerosus
• 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