FDA UDI In Commercial Distribution 🇺🇸 United States

Standard Imaging Exradin A12S Ion Chamber

DI: 00850019946314 · Model: 92725 · STANDARD IMAGING INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Standard Imaging Exradin A12S Ion Chamber
Primary DI
00850019946314
Version / Model
92725
Catalog Number
92725
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
f6e85043-3062-4117-99bd-cdb11a782781

Device Description

Standard Imaging Exradin A12S is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).

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
Yes

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 00850019946314