OsteoCool™ RF Ablation System

GUDID 00643169641211

GENERATOR OC01-R OSTEOCOOL RF REFURBISH

MEDTRONIC SOFAMOR DANEK, INC.

Radio-frequency ablation system generator Radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 00643169641211
• NIH Device Record Key: b6211ef6-ce1c-4cdc-8abd-2e4dff19b6e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoCool™ RF Ablation System
• Version Model Number: OC01-R
• 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: false
• Serial Number: true
• 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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169641211 [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

[00643169641211]

Moist Heat or Steam Sterilization

[00643169641211]

Moist Heat or Steam Sterilization

[00643169641211]

Moist Heat or Steam Sterilization

[00643169641211]

Moist Heat or Steam Sterilization

[00643169641211]

Moist Heat or Steam Sterilization

[00643169641211]

Moist Heat or Steam Sterilization

[00643169641211]

Moist Heat or Steam Sterilization

[00643169641211]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-07-29

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