Cavex ImpreSafe starterkit HA053

GUDID E241HA0530

Dental impression disinfectant

Cavex Holland B.V.

Denture cleanser

• Primary Device ID: E241HA0530
• NIH Device Record Key: f29ff9c9-10a0-4933-8c6f-8f8dbc2391c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cavex ImpreSafe starterkit
• Version Model Number: HA053
• Catalog Number: HA053
• Company DUNS: 419980156
• Company Name: Cavex Holland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true

Customer Support Contacts

• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl
• Phone: +31(0)235307700
• Email: r.woortman@cavex.nl

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E241HA0530 [Primary]

FDA Product Code

• LRJ: Disinfectant, Medical Devices

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-07

Devices Manufactured by Cavex Holland B.V.

• E241AA6000 - Cavex Cream: 2018-07-06 Dental Alginate Impression material
• E241AA6001 - Cavex Cream: 2018-07-06 Dental Alginate Impression material
• E241CE0900 - Cavex Temporary Cement: 2018-07-06 Dental Cement
• E241AA0200 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0201 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0250 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0251 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0350 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material