FDA UDI In Commercial Distribution 🇺🇸 United States

MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve

DI: 00616258021867 · Model: SSIT 96VLD · BAYER MEDICAL CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve
Primary DI
00616258021867
Version / Model
SSIT 96VLD
Catalog Number
SSIT 96VLD
Company Name
BAYER MEDICAL CARE INC.
Labeler DUNS
058716649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-10-25
Public Version
2
Public Version Date
2020-10-19
Public Version Status
Update
Public Device Record Key
92ff5201-d366-4334-961f-1bd76250c06a

Device Description

ASSY,TUBE SET,SOLARIS,96”,MC,WLD2 (86645343)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DXT Injector And Syringe, Angiographic

GMDN Terms

Code Name
15286 Angiographic syringe

Identifiers

Type ID
Package 40616258021865
Primary 00616258021867

Customer Contacts