FOLIFLEX PRO 1215125050

GUDID E23912151250501

No.

Dreve Dentamid GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: E23912151250501
• NIH Device Record Key: 60472f2a-4bbe-4951-bed9-cfd8a950e7e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOLIFLEX PRO
• Version Model Number: 1215125050
• Catalog Number: 1215125050
• Company DUNS: 388000846
• Company Name: Dreve Dentamid 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23912151250501 [Primary]

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

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: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [FOLIFLEX PRO]

• E23912301250501: No.
• E23912301200501: No.
• E23912401250501: No.
• E23912401200501: No.
• E23912251250501: No.
• E23912251200501: No.
• E23912151250501: No.
• E23912151200501: No.