Pressure Screw for Flexible Fixation Device for Gynecological Applicators GM11001860

GUDID 00816389022034

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389022034
• NIH Device Record Key: 9dbf60b4-7f74-4857-bdc5-33ef1985a568
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pressure Screw for Flexible Fixation Device for Gynecological Applicators
• Version Model Number: GM11001860
• Catalog Number: GM11001860
• 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	00816389022034 [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

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

Moist Heat or Steam Sterilization

[00816389022034]

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

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00855141006349 - Eclipse Treatment Planning System: 2024-12-30
• 00856100006370 - ARIA Radiation Therapy Management: 2024-12-30
• 10856100006223 - Gating Reflector Block: 2024-12-11
• 00850800006074 - Vitesee: 2024-11-11
• 00858086006467 - Varian Collimator Accessories 30 CM wedge set lower (JITKIT): 2024-10-07
• 00858086006474 - Varian Collimator Accessories 30 CM wedge set upper (JITKIT): 2024-10-07
• 00858086006481 - Varian Collimator Accessories 20 cm wedge set lower: 2024-10-07
• 00858086006498 - Varian Collimator Accessories Lead wedge set lower (JITKIT): 2024-10-07