Cardioblate™ CryoFlex™
GUDID 00643169983052
PROBE 60SF7-010 CRYOFLEX 7CM US
MEDTRONIC, INC.
General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 00643169983052 |
| NIH Device Record Key | 2ca86b3a-461d-4a61-8726-f44161d4fe2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardioblate™ CryoFlex™ |
| Version Model Number | 60SF7 |
| 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 | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 Centimeter |
| Length | 7 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. |
| 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 |
| 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 | 00643169983052 [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 | 2020-07-13 |
| Device Publish Date | 2020-07-03 |
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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