Duns Number:315620229
Catalog Number
401179
Brand Name
Sentus
Version/Model Number
ProMRI OTW QP S-75
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P070008,P070008
Product Code
OJX
Product Code Name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Public Device Record Key
994d17d7-4d5b-4704-be5e-f759e3ea0660
Public Version Date
September 22, 2021
Public Version Number
3
DI Record Publish Date
July 15, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 97 |
3 | A medical device with high risk that requires premarket approval | 402 |