Compu-Cutter 111

GUDID 00850077007163

Compu-cutter shielding bolck cutters cut foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment.

HUESTIS MACHINE CORPORATION

Radiation therapy beam block production hot-wire

• Primary Device ID: 00850077007163
• NIH Device Record Key: 0c00eb91-ee3f-4c34-bcb6-17fe01646055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compu-Cutter 111
• Version Model Number: CC3-1000
• Company DUNS: 001188390
• Company Name: HUESTIS MACHINE CORPORATION
• 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: false
• 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	00850077007163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940145

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-03

Devices Manufactured by HUESTIS MACHINE CORPORATION

• 00850077007286 - Huestis Medical Collimator: 2021-04-12 150PBL Collimator (Huestis Part # CM-32211-QMI)
• 00850077007279 - Huestis Medical Collimator: 2021-03-29 150PBL/SC Collimator (Huestis Part # CM-3201-102)
• 00850077007255 - Huestis Centralite Patient Positioning Laser: 2021-02-26 KIT CONTAINS 2 DLL-2 RED CROSS LASERS, 1 DLL-4 RED SAGITTAL LASER
• 00850077007262 - Huestis Centralite Patient Positioning Laser: 2021-02-26 KIT CONTAINS 2 DLG-2 GREEN CROSS LASERS, 1 DLG-4 GREEN SAGITTAL LASER
• 00850077007217 - Huestis Centralite Patient Positioning Laser: 2021-02-12 Green Diode Cross Laser
• 00850077007224 - Huestis Centralite Patient Positioning Laser: 2021-02-12 Red Diode Cross Laser
• 00850077007231 - Huestis Centralite Patient Positioning Laser: 2021-02-12 Red Diode Sagittal Laser
• 00850077007248 - Huestis Centralite Patient Positioning Laser: 2021-02-12 Green Diode Sagittal Laser