LINEAR IV 6573778

GUDID 60889976573778

R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE

CARESTREAM HEALTH, INC.

Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator

• Primary Device ID: 60889976573778
• NIH Device Record Key: 885f5992-3637-42d6-ac34-7c1318ac25b7
• Commercial Distribution Discontinuation: 2016-10-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LINEAR IV
• Version Model Number: LINEAR IV
• Catalog Number: 6573778
• 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	60889976573778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810598

FDA Product Code

• IZW: Collimator, automatic, 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: 2016-09-16

On-Brand Devices [LINEAR IV]

• 60889976573778: R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE
• 60889976568811: R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE