FDA UDI In Commercial Distribution 🇺🇸 United States

Catphan®

DI: 00812266030048 · Model: CTP700 · Providus Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Catphan®
Primary DI
00812266030048
Version / Model
CTP700
Company Name
Providus Holdings, Inc.
Labeler DUNS
104162493
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-28
Public Version
1
Public Version Date
2023-09-05
Public Version Status
New
Public Device Record Key
e66b3a00-4dea-4403-a649-cfdd770f5e20

Device Description

Catphan® 700, Complete Catphan® including housing, case, and Smári Image Analysis Database Service.

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
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IXF Test-Pattern, Radiographic

GMDN Terms

Code Name
40603 CT phantom, test object

Identifiers

Type ID
Primary 00812266030048