FDA UDI In Commercial Distribution 🇺🇸 United States

Pet / MR Pro-Tec, Syringe Shield

DI: 00718175009611 · Model: 007-961 · BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Pet / MR Pro-Tec, Syringe Shield
Primary DI
00718175009611
Version / Model
007-961
Catalog Number
007-961
Company Name
BIODEX MEDICAL SYSTEMS, INC.
Labeler DUNS
043833813
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-13
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
f4119f41-06f7-4cdc-82ad-0d88b5daa4cf

Device Description

Pet / MR Pro-Tec, Syringe Shield, Tungsten with Lead Glass Window, 3cc

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
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KPY Shield, Protective, Personnel

GMDN Terms

Code Name
38379 Syringe radiation shield

Identifiers

Type ID
Primary 00718175009611