Provox® Vega™ XtraSeal™ 8302

GUDID 07331791011061

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. Th

Atos Medical AB

Tracheoesophageal speech valve, indwelling, sterile

• Primary Device ID: 07331791011061
• NIH Device Record Key: 1164062e-2ad1-4927-91eb-02383dbc2e57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox® Vega™ XtraSeal™
• Version Model Number: 22.5 Fr
• Catalog Number: 8302
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com

Device Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791011061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090455

FDA Product Code

• EWL: Prosthesis, Laryngeal (Taub)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-12

On-Brand Devices [Provox® Vega™ XtraSeal™]

• 07331791011092: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011085: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011078: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011061: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011054: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011047: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011030: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011023: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011016: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791011009: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010996: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010989: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010972: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010965: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010958: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010941: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010934: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010927: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010583: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010576: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010569: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010552: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010545: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010538: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010521: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010514: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010507: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010491: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010484: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010477: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010460: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010453: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010446: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010439: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010422: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic
• 07331791010415: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voic