Duns Number:006261481
Device Description: CRTD DTMB1D1 AMPLIA MRI US DF1
Catalog Number
-
Brand Name
Amplia MRI™ CRT-D SureScan™
Version/Model Number
DTMB1D1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2021
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
ab97be1f-ee72-499b-a950-f6bf8b58591b
Public Version Date
December 22, 2021
Public Version Number
8
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 |