Guide tube, 4.5mm diameter x 700mm length, front open GM11003070

GUDID 00816389022461

Varian Medical Systems Deutschland GmbH

Tongue brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389022461
• NIH Device Record Key: 32ed831a-7119-40cc-82cd-3830fd954b4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide tube, 4.5mm diameter x 700mm length, front open
• Version Model Number: GM11003070
• Catalog Number: GM11003070
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• 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: false
• 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	00816389022461 [Primary]
GS1	10816389022468 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151022

FDA Product Code

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

Sterilization

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

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

[00816389022461]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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