Panoramic Corporation - Envision C1

GUDID 00862309000392

Envision C1: Digital Panoramic and Cephalometric X-Ray system (9768204014)

YOUNG PS ACQUISITION, LLC

Stationary extraoral dental x-ray system, digital
Primary Device ID00862309000392
NIH Device Record Keye8fe3568-d9f1-43a2-806f-d40bd9f28f43
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanoramic Corporation - Envision C1
Version Model Number9768204014
Company DUNS119620784
Company NameYOUNG PS ACQUISITION, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100862309000392 [Primary]

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-21
Device Publish Date2018-04-20

Devices Manufactured by YOUNG PS ACQUISITION, LLC

00862309000309 - Panoramic Corporation2018-07-06
00862309000316 - Panoramic Corporation2018-07-06 Unit, X-ray, Extraoral with timer-PC-1000/Laser 1000
00862309000330 - Panoramic Corporation2018-07-06 Unit, X-ray, Extraoral with Timer- PC-3000
00862309000347 - Panoramic Corporation2018-07-06 Unit, X-ray, Extraoral with Timer- PC-4000
00862309000354 - Panoramic Corporation2018-07-06 System, X-ray, Extraoral Source, Digital Encompass
00862309000361 - Panoramic Corporation2018-07-06 System, X-ray, Extraoral Source, Digital Encompass
00862309000378 - Panoramic Corporation2018-07-06 X-ray, Tomography, Computed, Dental - Encompass 3D
00862309000385 - Panoramic Corporation - Envision P2018-05-21 Envision P: Digital Panoramic X-Ray system (9768204013)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.