Rail lock assembly AL07388000

GUDID 00816389020856

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389020856
• NIH Device Record Key: 38845df1-7ff3-4395-9e1c-1a5e80c15b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rail lock assembly
• Version Model Number: AL07388000
• Catalog Number: AL07388000
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389020856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023220

FDA Product Code

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

Sterilization

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

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

[00816389020856]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-19

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