EDLENi Dental Sensor - Size 2

Basic Information

• Brand Name: EDLENi Dental Sensor - Size 2
• Primary DI: 00862973000353
• Version / Model: S11685-16-43
• Company Name: EDLEN IMAGING, LLC
• Labeler DUNS: 078801340
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: da9a97ca-c663-4afd-809a-a145c56fd23c

Device Description

EDLENi Dental Sensor, CMOS image sensor, CsI Scintillator, 2.5 meter cable

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: 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
MUH	System,X-Ray,Extraoral Source,Digital	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44905	Dental digital imaging sensor, intraoral	An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862973000353	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	41.9	Millimeter
Width	30.4	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius