OsteoCool™ 2.0 RF Ablation System

GUDID 00763000764050

CART OCA01-100 OC 2.0 100W STAND

MEDTRONIC SOFAMOR DANEK, INC.

Medical device integration rack

• Primary Device ID: 00763000764050
• NIH Device Record Key: 5da2a5c6-5756-4671-ba04-0ad4e3ffb89b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoCool™ 2.0 RF Ablation System
• Version Model Number: OCA01-100
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• 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
• 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
• 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	00763000764050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233830

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [OsteoCool™ 2.0 RF Ablation System]

• 00763000764043: HUB OC04-100 OC 2.0 100W
• 00763000764029: PUMP OC02-100 OC 2.0 100W RF
• 00763000764005: GENERATOR OC01-100 OC 2.0 RF 100W
• 00763000764050: CART OCA01-100 OC 2.0 100W STAND
• 00763000764067: CABLE OC03-100 OC 2.0 100W CABLE
• 00763000764036: PUMP OC02-R-100 OC 2.0 100W RF REFURB
• 00763000764012: GENERATOR OC01-R-100 OC 2.0 100W REFURB