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 Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital

• Primary Device ID: 00862309000392
• NIH Device Record Key: e8fe3568-d9f1-43a2-806f-d40bd9f28f43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panoramic Corporation - Envision C1
• Version Model Number: 9768204014
• Company DUNS: 119620784
• Company Name: YOUNG PS ACQUISITION, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862309000392 [Primary]

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-05-21
• Device Publish Date: 2018-04-20

Devices Manufactured by YOUNG PS ACQUISITION, LLC

• 00862309000309 - Panoramic Corporation: 2018-07-06
• 00862309000316 - Panoramic Corporation: 2018-07-06 Unit, X-ray, Extraoral with timer-PC-1000/Laser 1000
• 00862309000330 - Panoramic Corporation: 2018-07-06 Unit, X-ray, Extraoral with Timer- PC-3000
• 00862309000347 - Panoramic Corporation: 2018-07-06 Unit, X-ray, Extraoral with Timer- PC-4000
• 00862309000354 - Panoramic Corporation: 2018-07-06 System, X-ray, Extraoral Source, Digital Encompass
• 00862309000361 - Panoramic Corporation: 2018-07-06 System, X-ray, Extraoral Source, Digital Encompass
• 00862309000378 - Panoramic Corporation: 2018-07-06 X-ray, Tomography, Computed, Dental - Encompass 3D
• 00862309000385 - Panoramic Corporation - Envision P: 2018-05-21 Envision P: Digital Panoramic X-Ray system (9768204013)