Collimare

GUDID 00862005000320

Collimator, Portable Certified, 125kVp, LED 25W

COLLIMARE, LLC

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

• Primary Device ID: 00862005000320
• NIH Device Record Key: c5fb802f-7915-43d8-ac2e-cdeaae00643f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collimare
• Version Model Number: CPL-125-0001-C
• Company DUNS: 626743954
• Company Name: COLLIMARE, LLC
• 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: false
• Serial Number: true
• 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	00862005000320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073124

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: 2016-09-28

On-Brand Devices [Collimare]

• 00862005000368: Collimator, Selectable Certified, 150kVp, LED 25W
• 00862005000351: Collimator, Manual Certified, 150kVp, LED 25W, CMR
• 00862005000344: Collimator, Portable Certified, 125kVp, LED 25W, MX
• 00862005000337: Collimator, Portable Certified, 125kVp, LED 25W, SR
• 00862005000320: Collimator, Portable Certified, 125kVp, LED 25W
• 00862005000313: Collimator, Manual Certified, 125kVp, LED 25W
• 00862005000306: Collimator, Manual Certified, 150kVp, LED 25W