LINEAR MC 150 1015148

GUDID 60889976567166

R40-S-P PINNACLE MTRZD COLLIMATOR

CARESTREAM HEALTH, INC.

Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized

• Primary Device ID: 60889976567166
• NIH Device Record Key: 1ae8e54a-a552-442f-91e3-7f64ad64c5ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINEAR MC 150
• Version Model Number: LINEAR MC 150
• Catalog Number: 1015148
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, 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: false
• Serial Number: true
• 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	60889976567166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810598

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: 2016-09-23

On-Brand Devices [LINEAR MC 150]

• 60889976573785: R40-M-R MANUAL COLLIMATOR FOR DR
• 60889976567166: R40-S-P PINNACLE MTRZD COLLIMATOR
• 60889976567159: R40-M-P PROGENY MC150 MANUAL COLLIMATOR
• 60889971058942: MOTORIZED COLLIMATOR - CHINA (DR)