Duns Number:058716649
Device Description: " MRInnervu Prostate Endorectal Coil, Compatible with 3.0 Tesla for GE, Siemens, and Marco " MRInnervu Prostate Endorectal Coil, Compatible with 3.0 Tesla for GE, Siemens, and Marconi.(COIL,DISPOSABLE ENDORECTAL 3.0T,MC)(60727498)"
Catalog Number
BPX 30
Brand Name
MEDRAD® Disposable Prostate Coil
Version/Model Number
BPX 30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051349,K051349
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
1a30ec74-d0cb-434e-917e-c88d13bd3ca8
Public Version Date
March 05, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10616258009251
Quantity per Package
5
Contains DI Package
00616258009254
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |