OptaBlate 9700-020-100
GUDID 07613327524482
20 mm Probe Single Kit
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 | 07613327524482 |
| NIH Device Record Key | 445a2398-4ed1-4d47-a2ba-139431996c9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptaBlate |
| Version Model Number | 9700020100 |
| Catalog Number | 9700-020-100 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM |
Device Dimensions
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327524482 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221074
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
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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