FDA UDI In Commercial Distribution 🇺🇸 United States

ECTphan™ 330

DI: 00812266030598 · Model: SMR330 · Providus Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ECTphan™ 330
Primary DI
00812266030598
Version / Model
SMR330
Catalog Number
SMR330
Company Name
Providus Holdings, Inc.
Labeler DUNS
104162493
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-03-11
Public Version
1
Public Version Date
2024-03-19
Public Version Status
New
Public Device Record Key
36eee4da-65f5-4bda-b32b-bc9a8041f3fc

Device Description

ECTphan™ 330, Complete ECTphan™ included, MTF point source holder and 3SMR341 low contrast inserts and cantilever case mounting system

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
40616 Multi-modality diagnostic imaging phantom, test object

Identifiers

Type ID
Primary 00812266030598