SynchroWave LT Antenna SW-1415

GUDID 00810563021004

Long Tip Microwave Antenna Kit (15 cm, 1 per Tray)

VARIAN MEDICAL SYSTEMS, INC.

Microwave ablation system probe

• Primary Device ID: 00810563021004
• NIH Device Record Key: 26fb1bf8-d6c2-443e-833c-f5cf55ee1129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynchroWave LT Antenna
• Version Model Number: 22-17025-015
• Catalog Number: SW-1415
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563021004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141785

FDA Product Code

• NEY: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

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: 2022-02-28
• Device Publish Date: 2022-02-18

On-Brand Devices [SynchroWave LT Antenna]

• 00810563021028: Long Tip Microwave Antenna Kit (25 cm, 1 per Tray)
• 00810563021011: Long Tip Microwave Antenna Kit (20 cm, 1 per Tray)
• 00810563021004: Long Tip Microwave Antenna Kit (15 cm, 1 per Tray)