Titanium needle 113mm, 16 gauge (1.65mm), sharp trocar point GM11010210

GUDID 00816389029330

Varian Medical Systems Deutschland GmbH

Brachytherapy needle

• Primary Device ID: 00816389029330
• NIH Device Record Key: 2e4e1e8f-6908-4e66-b4af-3de3ff8eeb70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titanium needle 113mm, 16 gauge (1.65mm), sharp trocar point
• Version Model Number: GM11010210
• Catalog Number: GM11010210
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00816389029330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093291

FDA Product Code

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

Sterilization

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

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

[00816389029330]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-17
• Device Publish Date: 2021-12-09

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