Obturator and Caps

GUDID 00860005821204

CONCURE ONCOLOGY, INC.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00860005821204
• NIH Device Record Key: f47c0bec-865e-4748-ac7f-cc3aa5d4e374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Obturator and Caps
• Version Model Number: 530312
• Company DUNS: 056124661
• Company Name: CONCURE ONCOLOGY, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00860005821204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060349

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-27
• Device Publish Date: 2021-04-19

Devices Manufactured by CONCURE ONCOLOGY, INC.

• 00860005821204 - Obturator and Caps: 2021-04-27
• 00860005821204 - Obturator and Caps: 2021-04-27
• 00860005821211 - BMT Localizer Needle Kit: 2021-04-27
• 00860003072714 - BMT Template Grid Armature & Table Clamp: 2020-08-13
• 00860003072721 - BMT Armrest Armature & Table Clamp: 2020-08-13
• 00860003072738 - BMT Template Grid, Vertical Lock, Large: 2020-08-13
• 00860003072745 - BMT Cleaning Brush Set, Vertical Lock: 2020-08-13
• 00860003072752 - BMT Fiducial Needle, Sharp: 2020-08-13
• 00860003072769 - BMT Fiducial Needle, Round: 2020-08-13