Varian RPM Gating Marker Block (2 Dot) 1107081-01

GUDID 10858086006389

VARIAN MEDICAL SYSTEMS, INC.

Real-time position management respiratory gating system, optical

• Primary Device ID: 10858086006389
• NIH Device Record Key: 181cc82b-755e-4b9b-95a7-338ebace28db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varian RPM Gating Marker Block (2 Dot)
• Version Model Number: 1107081-01
• Catalog Number: 1107081-01
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858086006382 [Primary]
GS1	10858086006389 [Package]; Contains: 00858086006382; Package: 5-Pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102024

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2021-03-16
• Device Publish Date: 2021-03-08

On-Brand Devices [Varian RPM Gating Marker Block (2 Dot)]

• 10858086006389: 1107081-01
• 10858086006617: 1107081-02