AccessGUDID - DEVICE: Panoramic Corporation (00862309000316)

GUDID

Device Identifier (DI) Information

Brand Name: Panoramic Corporation
Version or Model: PC-1000/Laser 1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: YOUNG PS ACQUISITION, LLC

Primary DI Number: 00862309000316
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 119620784 *Terms of Use

Device Description: Unit, X-ray, Extraoral with timer-PC-1000/Laser 1000

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):	No
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?
42066	Stationary extraoral dental x-ray system, analogue	A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. 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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K882436	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: 355d6f84-89d5-4357-910c-7b88776c4915
Public Version Date: September 27, 2022
Public Version Number: 5
DI Record Publish Date: May 24, 2017