FDA UDI In Commercial Distribution 🇺🇸 United States

PreXion3D Expedition

DI: 04589557760071 · Model: P04B · PREXION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PreXion3D Expedition
Primary DI
04589557760071
Version / Model
P04B
Company Name
PREXION CORPORATION
Labeler DUNS
712093244
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-05-20
Public Version
1
Public Version Date
2024-05-28
Public Version Status
New
Public Device Record Key
c9eabdc9-9c94-4feb-9fe0-826929d98aeb

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
OAS X-Ray, Tomography, Computed, Dental

GMDN Terms

Code Name
61019 Cone beam computed tomography system, head/neck

Identifiers

Type ID
Primary 04589557760071