Provox® Vega™ XtraSeal™ 8293
GUDID 07331791010972
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 | 07331791010972 |
| NIH Device Record Key | c776e342-2867-42c6-8413-a2627ad63b26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provox® Vega™ XtraSeal™ |
| Version Model Number | 17 Fr |
| Catalog Number | 8293 |
| 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 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com |
Device Dimensions
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
| Length | 15 Millimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| 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 |
| 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 away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07331791010972 [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 |
Trademark Results [Provox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROVOX 79210309 5409638 Live/Registered |
Atos Medical AB 2017-02-14 |
 PROVOX 76349647 2754078 Live/Registered |
OCI CHEMICAL CORPORATION 2001-12-17 |
 PROVOX 76147409 2577722 Live/Registered |
ProVox Acquisition, LLC 2000-10-16 |
 PROVOX 74475578 1897386 Live/Registered |
FISHER CONTROLS INTERNATIONAL LLC 1993-12-30 |
 PROVOX 74351050 1790270 Live/Registered |
Atos Medical Aktiebolag 1993-01-22 |
 PROVOX 73596607 1433643 Dead/Cancelled |
FISHER CONTROLS INTERNATIONAL, INC. 1986-05-02 |
 PROVOX 73283731 1188502 Dead/Cancelled |
Fisher Controls Company, Inc. 1980-10-28 |
 PROVOX 73150306 1108475 Dead/Expired |
FISHER CONTROLS COMPANY, INC. 1977-11-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.