Duns Number:006261481
Device Description: CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1
Catalog Number
-
Brand Name
Amplia MRI™ Quad CRT-D SureScan™
Version/Model Number
DTMB1Q1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2019
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
e3bfdb65-6bc7-489d-a3bc-045bc48db976
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
December 11, 2016
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 |