FDA UDI In Commercial Distribution 🇺🇸 United States

Panoramic Corporation - Envision C1

DI: 00862309000392 · Model: 9768204014 · YOUNG PS ACQUISITION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Panoramic Corporation - Envision C1
Primary DI
00862309000392
Version / Model
9768204014
Company Name
YOUNG PS ACQUISITION, LLC
Labeler DUNS
119620784
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-04-20
Public Version
2
Public Version Date
2022-09-27
Public Version Status
Update
Public Device Record Key
e8fe3568-d9f1-43a2-806f-d40bd9f28f43

Device Description

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

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
45855 Stationary extraoral dental x-ray system, digital

Identifiers

Type ID
Primary 00862309000392