Collimare

Basic Information

• Brand Name: Collimare
• Primary DI: 00862005000351
• Version / Model: CML-150-CMR1-C
• Company Name: COLLIMARE, LLC
• Labeler DUNS: 626743954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f589aff7-cade-4b2c-b453-f6582e52ee01

Device Description

Collimator, Manual Certified, 150kVp, LED 25W, CMR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZX	Collimator, Manual, Radiographic	Radiology	892.1610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42253	Manual-aperture-control diagnostic x-ray system collimator, non-motorized	A standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use. It includes designs with manual controls that operate one or more shutter pairs and also designs that require the addition or removal of attachments or extensions that allow the operator to alter the size and shape of the exit beam from a cone or cylinder. An x-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862005000351	GS1

Premarket Submissions

Submission Number	Supplement Number
K073124	000