Collimator ML01 II

Basic Information

• Brand Name: Collimator ML01 II
• Primary DI: 04056869011554
• Version / Model: 10092611
• Company Name: Siemens Healthcare GmbH
• Labeler DUNS: 313217003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-02
• Public Version: 4
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 5f613553-a414-4cfb-947c-ccc98361dac1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
KPW	Device, beam limiting, x-ray, diagnostic	Radiology	892.1610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42252	Manual-aperture-control diagnostic x-ray system collimator, motorized	A standard, diagnostic x-ray beam-limiting and shaping device with a motorized shutter/length adjustment mechanism that requires the operator to manually adjust the collimator shutters or length of the cone prior to an exposure in order to match the size and shape of the x-ray beam to the size of the x-ray cassette in use. Most motorized collimator assemblies include a light-centring device. 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	04056869011554	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 20 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal