FDA UDI In Commercial Distribution 🇺🇸 United States

Pro-Tec Pet Syringe Shield

DI: 00718175009987 · Model: 007-967 · BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Pro-Tec Pet Syringe Shield
Primary DI
00718175009987
Version / Model
007-967
Catalog Number
007-967
Company Name
BIODEX MEDICAL SYSTEMS, INC.
Labeler DUNS
043833813
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-10-16
Public Version
1
Public Version Date
2019-10-24
Public Version Status
New
Public Device Record Key
bc78be65-9d0e-4b87-aa3c-cdc4768bad2c

Device Description

SYRINGE SHIELD, PET/MRI, without GLASS, 5cc

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 00718175009987