HI-EN Collimator Asm Symbia

Basic Information

• Brand Name: HI-EN Collimator Asm Symbia
• Primary DI: 04056869001982
• Version / Model: 07332054
• Catalog Number: 7332054..
• Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Labeler DUNS: 868230876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: f785b838-d1fe-4abb-9b7c-07574c156671

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: 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
KPS	System, tomography, computed, emission	Radiology	892.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42258	Multi-hole nuclear medicine system collimator, low-energy	A device designed specifically for use in diagnostic nuclear medicine imaging applications operating with an energy range of less than 500 kilo-electronvolt (keV). It consists of an array of small openings drilled or cast into a flat sheet or plate of lead or lead-equivalent materials. Its size and shape is intended to conform to the crystal shape of a nuclear medicine imaging system to ensure that only gamma ray activity directly in front of the individual collimator channels reaches the scintillation. It has attachment mechanisms that enable it to be safely transported, removed from, and attached to the detector head of the system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056869001982	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142006	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -20 – 49 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 49 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity