OptaBlate 9700-815-015
GUDID 07613327524505
150MM Temperature Sensor
STRYKER CORPORATION
Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar| Primary Device ID | 07613327524505 |
| NIH Device Record Key | efb1541e-f34c-4de6-972d-816637d370f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptaBlate |
| Version Model Number | 9700815015 |
| Catalog Number | 9700-815-015 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +0018002533210 |
| INST.STRYKER.CS@STRYKER.COM |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327524505 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221074
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[07613327524505]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-03 |
| Device Publish Date | 2022-09-23 |
On-Brand Devices [OptaBlate]
| 07613327547610 | RF GENERATOR |
| 07613327524505 | 150MM Temperature Sensor |
| 07613327524482 | 20 mm Probe Single Kit |
| 07613327524475 | 15MM Probe Single Kit |
| 07613327524512 | 15 mm Probe Dual Kit |
| 07613327524499 | 20 mm Probe Dual Kit |
| 37613327591553 | 11G HAND DRILL PACK |
Trademark Results [OptaBlate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTABLATE 90383301 not registered Live/Pending |
Stryker Corporation 2020-12-15 |
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