Cardioblate™ CryoFlex™
GUDID 00643169983038
PROBE 60SF2-010 CRYOFLEX 10CM US
MEDTRONIC, INC.
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 00643169983038 |
| NIH Device Record Key | 78509587-9387-4911-9498-0cef4384bfc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardioblate™ CryoFlex™ |
| Version Model Number | 60SF2 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169983038 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191526
FDA Product Code
| OCL | Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue |
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 | 2019-11-25 |
| Device Publish Date | 2019-11-17 |
On-Brand Devices [Cardioblate™ CryoFlex™]
| 00643169983069 | CLAMP 60CM1-010 CRYOFLEX PROBE US |
| 00643169983045 | PROBE 60SF3-010 CRYOFLEX 10-S US |
| 00643169983038 | PROBE 60SF2-010 CRYOFLEX 10CM US |
| 00643169983052 | PROBE 60SF7-010 CRYOFLEX 7CM US |
Trademark Results [Cardioblate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOBLATE 78264538 2875737 Live/Registered |
Medtronic, Inc. 2003-06-19 |
 CARDIOBLATE 76017616 2672681 Dead/Cancelled |
Medtronic, Inc. 2000-03-29 |
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