FDA UDI In Commercial Distribution 🇺🇸 United States

Standard Imaging Needle Loading Shield

DI: 00850019946048 · Model: 90070 · STANDARD IMAGING INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Standard Imaging Needle Loading Shield
Primary DI
00850019946048
Version / Model
90070
Catalog Number
90070
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
0c5dbb1c-9b21-48e9-9821-e50ecb7138df

Device Description

Standard Imaging Needle Loading Shield provide a convenient work station for counting and handling seeds and for loading into needles in a radiation shielded environment.

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
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
KPY Shield, Protective, Personnel

GMDN Terms

Code Name
40905 Radiation shielding container, general-purpose

Identifiers

Type ID
Primary 00850019946048