Provox Dilator 8341

GUDID 07331791181191

Atos Medical AB

Tracheoesophageal fistula dilator, single-use

• Primary Device ID: 07331791181191
• NIH Device Record Key: b147abbc-bbe7-4246-a2e7-54e2566d1228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox Dilator
• Version Model Number: 8341
• Catalog Number: 8341
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791181191 [Unit of Use]
GS1	07331791181207 [Primary]

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL SURGICAL

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: 2025-02-17
• Device Publish Date: 2025-02-08

On-Brand Devices [Provox Dilator]

• 07331791000850: The Provox Dilator is intended for upsizing smaller tracheo-esophageal (TE) punctures (i.e. from
• 07331791181191: 8341