Leak Stop Channel Marker - Channel 14 - 25 pack Not Sold Separately

GUDID 00816389028647

VARIAN MEDICAL SYSTEMS, INC.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389028647
• NIH Device Record Key: 5ed2a4f1-0243-446c-aa6b-a2aed4477be6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leak Stop Channel Marker - Channel 14 - 25 pack
• Version Model Number: Channel 14
• Catalog Number: Not Sold Separately
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00816389028647 [Unit of Use]
GS1	10816389028644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152018

FDA Product Code

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

Sterilization

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

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

[00816389028647]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-18
• Device Publish Date: 2020-11-11

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00850800006074 - Vitesee: 2024-11-11
• 00858086006467 - Varian Collimator Accessories 30 CM wedge set lower (JITKIT): 2024-10-07
• 00858086006474 - Varian Collimator Accessories 30 CM wedge set upper (JITKIT): 2024-10-07
• 00858086006481 - Varian Collimator Accessories 20 cm wedge set lower: 2024-10-07
• 00858086006498 - Varian Collimator Accessories Lead wedge set lower (JITKIT): 2024-10-07
• 00858086006504 - Varian Collimator Accessories Lead wedge set upper (JITKIT): 2024-10-07
• 00858086006511 - Varian Collimator Accessories Upper port film graticule for MLC: 2024-10-07
• 00858086006528 - Varian Collimator Accessories Upper port film graticule for MLC: 2024-10-07