LEHR Collimator

Basic Information

• Brand Name: LEHR Collimator
• Primary DI: 00850816007027
• Version / Model: LEHR
• Company Name: DIGIRAD CORPORATION
• Labeler DUNS: 148548738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b9ee0578-b893-4a76-86ca-e22f0e402623

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: 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
IYX	Camera, Scintillation (Gamma)	Radiology	892.1100	1

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	00850816007027	GS1

Customer Contacts

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