FDA UDI In Commercial Distribution 🇺🇸 United States

Standard Imaging Exradin W1 Scintillator

DI: 00850019946482 · Model: 92739 · STANDARD IMAGING INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Standard Imaging Exradin W1 Scintillator
Primary DI
00850019946482
Version / Model
92739
Catalog Number
92739
Company Name
STANDARD IMAGING INC.
Labeler DUNS
788084705
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-22
Public Version
1
Public Version Date
2023-06-30
Public Version Status
New
Public Device Record Key
2b434ffd-a780-47eb-84db-62706ca85c28

Device Description

Standard Imaging Exradin W1 Scintillator is a plastic scintillating fiber-based detector designed for highly accurate measurement of small radiotherapy fields used in patient plan verification and machine commissioning and QA procedures.

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
Yes
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
LHO Instrument, Quality-Assurance, Radiologic

GMDN Terms

Code Name
38323 Radiation condenser R-meter

Identifiers

Type ID
Primary 00850019946482