Stainless steel needle, 113mm, 1.65mm diameter, trocar point GM11003350

GUDID 00816389022560

For Prostate and Perineal Implant Template Set, Breast Implant Template Set, Interstitial Applicator Set

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389022560
• NIH Device Record Key: fdcfb625-e3e6-44aa-b131-565f24a7ef23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stainless steel needle, 113mm, 1.65mm diameter, trocar point
• Version Model Number: GM11003350
• Catalog Number: GM11003350
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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	00816389022560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952913

FDA Product Code

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

Sterilization

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

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

[00816389022560]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-10
• Device Publish Date: 2021-02-02

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