VAPR VUE 227214
GUDID 10886705009657
VAPR VUE Wireless Footswitch
Medos International Sàrl
Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical| Primary Device ID | 10886705009657 |
| NIH Device Record Key | a741787a-d56d-4d50-b488-9f0d9b29f0e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VAPR VUE |
| Version Model Number | 227214 |
| Catalog Number | 227214 |
| Company DUNS | 482661753 |
| Company Name | Medos International Sàrl |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705009657 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100638
FDA Product Code
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-05-14 |
| Device Publish Date | 2015-09-01 |
Devices Manufactured by Medos International Sàrl
| 10705034507811 - VIPER PRIME | 2024-04-11 VIPER PRIME STYLET |
| 10705034507828 - VIPER PRIME | 2024-04-11 VIPER PRIME NAVIGATION STYLET |
| 10886705012367 - COR | 2024-03-27 COR Disposable Kit, 6mm |
| 10886705012374 - COR | 2024-03-27 COR Disposable Kit, 8mm |
| 10886705012381 - COR | 2024-03-27 COR Disposable Kit, 10mm |
| 10886705012404 - COR | 2024-03-27 COR Disposable Kit, 8mm w/Perpendicularity |
| 10886705012398 - COR | 2024-03-18 COR Disposable Kit, 6mm w/Perpendicularity |
| 10886705012411 - COR | 2024-03-18 COR Disposable Kit, 10mm w/Perpendicularity |
Trademark Results [VAPR VUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAPR VUE 77954185 4147108 Live/Registered |
JOHNSON & JOHNSON 2010-03-09 |
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