BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Stellaris 2D

DI: E3158468600007 · Model: 8468600007 · BLUO ELECTRONICS SRL

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Stellaris 2D
Primary DI: E3158468600007
Version / Model: 8468600007
Company Name: BLUO ELECTRONICS SRL
Labeler DUNS: 514320345
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-04-29
Public Version: 2
Public Version Date: 2023-07-28
Public Version Status: Update
Public Device Record Key: 7d19ecdc-205d-400b-a29c-29f95ab03682

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
OAS	X-Ray, Tomography, Computed, Dental	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43369	Stationary panoramic dental x-ray system, digital	A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E3158468600007	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K213579	000

Storage Conditions

Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal
Type: Handling Environment Humidity
Temperature Range: 30 – 75 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal
Type: Storage Environment Humidity
Temperature Range: 20 – 80 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -10 – 50 Degrees Celsius