Blue locking collets for 2.0 mm needles (pack of 25) GM11012270

GUDID 00816389020290

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389020290
• NIH Device Record Key: cf3059cb-a51a-45c1-b036-bcbd43f7fdd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue locking collets for 2.0 mm needles (pack of 25)
• Version Model Number: GM11012270
• Catalog Number: GM11012270
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 25
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00816389020290 [Unit of Use]
GS1	10816389020297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232949

FDA Product Code

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

Sterilization

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

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

[00816389020290]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

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• 00816389020344 - Transfer Guide Tube + for 250 mm catheters: 2024-02-28
• 10816389020358 - Transfer Guide Tube + of 500 mm length for catheters: 2024-02-28