Cervical sleeve, 3 mm aperture, 20 mm length, single use AL13142000

GUDID 00816389021341

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389021341
• NIH Device Record Key: 0d0c641e-dd59-4c84-9057-52bf5f719aaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical sleeve, 3 mm aperture, 20 mm length, single use
• Version Model Number: AL13142000
• Catalog Number: AL13142000
• 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: 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 Dimensions

• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389021341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172675
• Premarket Notification: K955844

FDA Product Code

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

Sterilization

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

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

[00816389021341]

Hydrogen Peroxide

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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