Sterilization Box for Fletcher-style applicators, defined geometry, GM11010320

GUDID 00816389028364

(GM11000810 & GM11006200)

VARIAN MEDICAL SYSTEMS, INC.

Sterilization/disinfection container

• Primary Device ID: 00816389028364
• NIH Device Record Key: 8a2fbceb-faba-46cb-93e5-8282cf0437bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilization Box for Fletcher-style applicators, defined geometry,
• Version Model Number: GM11010320
• Catalog Number: GM11010320
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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	00816389028364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160021

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-27

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00858086006931 - IDENTIFY: 2025-12-30
• 00810563022629 - Guiding tube 60 degrees ring for central needle: 2025-12-03
• 00816389028937 - Guided Aarhus Applicator Set: 2025-12-03
• 00816389028944 - Guided Aarhus vaginal template 60 degrees,ø 28 mm: 2025-12-03
• 00816389028951 - Guided Aarhus vaginal template 60 degrees, ø 32 mm: 2025-12-03
• 00816389028968 - Guided Aarhus vaginal template 60 degrees, ø 36 mm: 2025-12-03
• 00816389028975 - Guide tube collector for up to 7 needles: 2025-12-03
• 00816389028982 - Guide tube collector for up to 11 needles: 2025-12-03