OsteoCool™ RF Ablation System
GUDID 00643169546462
CONNECTOR OC04 OSTEOCOOL HUB
MEDTRONIC SOFAMOR DANEK, INC.
Radio-frequency ablation system| Primary Device ID | 00643169546462 |
| NIH Device Record Key | 065b6f73-447c-436b-9a60-6504726bfcfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoCool™ RF Ablation System |
| Version Model Number | OC04 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | 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)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169546462 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152057
FDA Product Code
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
[00643169546462]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-03-31 |
On-Brand Devices [OsteoCool™ RF Ablation System]
| 00643169871625 | PROBE OCP215 OSTEOCOOL RF 17G 15MMX2 |
| 00643169871618 | PROBE OCP115 OSTEOCOOL RF 17G 15MM |
| 00643169674714 | PUMP UNIT OC02-R OSTEOCOOL RF REFURBISH |
| 00643169641211 | GENERATOR OC01-R OSTEOCOOL RF REFURBISH |
| 00643169585669 | CART OCA01 OSTEOCOOL CART STAND |
| 00643169585652 | STAND OCA02 OSTEOCOOL DESK STAND |
| 00643169546462 | CONNECTOR OC04 OSTEOCOOL HUB |
| 00643169546400 | CABLE OC03 OSTEOCOOL RF PUMP CABLE |
| 00643169546394 | PUMP UNIT OC02 OSTEOCOOL RF PUMP |
| 00643169546301 | GENERATOR OC01 OSTEOCOOL RF GENERATOR |
| 00643169546264 | wHERMOCOUPLE OCN001 OSTEOCOOL ITC 145MM |
| 00643169546233 | PROBE KIT OCP120 OSTEOCOOL RF 17G 20MM |
| 00643169546226 | PROBE KIT OCP110 OSTEOCOOL RF 17G 10MM |
| 00643169546219 | PROBE KIT OCP107 OSTEOCOOL RF 17G 7MM |
| 00643169578920 | PROBE OCP220 OSTEOCOOL RF 17G 20MMX2 |
| 00643169578913 | PROBE OCP210 OSTEOCOOL RF 17G 10MMX2 |
| 00643169578906 | PROBE OCP207 OSTEOCOOL RF 17G 7MMX2 |
| 00763000167639 | GENERATOR OC01 OSTEOCOOL RF GENERATOR |
| 00763000157845 | CONNECTOR OC04 OSTEOCOOL HUB |
Trademark Results [OsteoCool]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOCOOL 85444515 4219326 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 2011-10-11 |
 OSTEOCOOL 85444494 4150186 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 2011-10-11 |
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