AccessGUDID - DEVICE: Planmeca ProOne (06430035420322)

GUDID

Device Identifier (DI) Information

Brand Name: Planmeca ProOne
Version or Model: ProOne
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30010469
Company Name: Planmeca Oy

Primary DI Number: 06430035420322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368788568 *Terms of Use

Device Description: Planmeca ProOne is a dental panoramic X-ray imaging system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.

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):	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUH	System,X-Ray,Extraoral Source,Digital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072244	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 902d09f3-62da-4b45-ae83-2a9b468c22e6
Public Version Date: April 21, 2021
Public Version Number: 5
DI Record Publish Date: August 10, 2016