Duns Number:106295384
Device Description: Cardiac Resynchronization Therapy Defibrillator
Catalog Number
-
Brand Name
DYNAGEN™ CRT-D
Version/Model Number
G154
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012
Product Code
NIK
Product Code Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Public Device Record Key
e2394d4c-c617-4a1a-891a-78b1375e5e2e
Public Version Date
October 18, 2021
Public Version Number
7
DI Record Publish Date
November 06, 2014
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |