Duns Number:006261481
Device Description: CRTD DTMA1D1 CLARIA MRI US DF1
Catalog Number
-
Brand Name
Claria MRI™ CRT-D SureScan™
Version/Model Number
DTMA1D1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 2020
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NIK
Product Code Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Public Device Record Key
fad53b85-00c1-4f24-9d98-c05d5dffd78d
Public Version Date
March 16, 2021
Public Version Number
7
DI Record Publish Date
May 14, 2017
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |