Huestis Medical Collilmator

GUDID 00850077007187

X-Ray Collimator, Automatic, Huestis Part # CM-42054-102 (PBL-RRE/RXL/SF)

HUESTIS MACHINE CORPORATION

Automatic-aperture-control diagnostic x-ray system collimator

• Primary Device ID: 00850077007187
• NIH Device Record Key: aed06de2-a3d4-48da-8a6a-07c7d9a95816
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Huestis Medical Collilmator
• Version Model Number: CM-42054-102
• 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	00850077007187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972966

FDA Product Code

• IZX: Collimator, Manual, Radiographic

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: 2017-11-02

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