AccessGUDID - DEVICE: PantOs 16 xp Ceph (E31584682005000)

GUDID

Device Identifier (DI) Information

Brand Name: PantOs 16 xp Ceph
Version or Model: 8468200500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BLUO ELECTRONICS SRL

Primary DI Number: E31584682005000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514320345 *Terms of Use

Device Description: Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44262	Stationary panoramic dental x-ray system, analogue	A diagnostic analogue 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) images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware or software components. The image is from film or phosphor plate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHD	Unit, X-Ray, Extraoral With Timer
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUH	System,X-Ray,Extraoral Source,Digital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031801	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between .5 and 1.06 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bbfd0b73-d0fb-4d41-9c48-9809889047ee
Public Version Date: July 28, 2023
Public Version Number: 4
DI Record Publish Date: September 10, 2016