Provox® Vega™ Puncture Set 8148US

GUDID 07331791009167

The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that

Atos Medical AB

Tracheoesophageal speech valve, indwelling, sterile

• Primary Device ID: 07331791009167
• NIH Device Record Key: 374ba8fc-0d11-44f0-9289-53ebc548dc49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox® Vega™ Puncture Set
• Version Model Number: 22.5 Fr
• Catalog Number: 8148US
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Dimensions

• Length: 10 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791009167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131947

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: 2016-09-11

On-Brand Devices [Provox® Vega™ Puncture Set]

• 07331791009174: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009167: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009150: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009143: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009136: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009129: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009112: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009105: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009099: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s
• 07331791009082: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with s