Cleaning Caps, black (pack of 20) GM11003220

GUDID 00816389029415

VARIAN MEDICAL SYSTEMS, INC.

Tongue brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389029415
• NIH Device Record Key: 64acb515-3ee1-4ce8-b00e-f1cadc493b1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cleaning Caps, black (pack of 20)
• Version Model Number: GM11003220
• Catalog Number: GM11003220
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 20
• 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: false
• 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	00816389029415 [Unit of Use]
GS1	10816389029412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141336

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

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: 2022-02-07
• Device Publish Date: 2022-01-29

On-Brand Devices [Cleaning Caps, black (pack of 20)]

• 10816389027135: GM11003220
• 00816389029415: GM11003220