Duns Number:106295384
Device Description: Subcutaneous Implantable Cardioverter Defibrillator
Catalog Number
-
Brand Name
EMBLEM™ MRI S-ICD
Version/Model Number
A219
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P110042,P110042,P110042,P110042,P110042,P110042,P110042,P110042,P110042,P110042,P110042
Product Code
LWS
Product Code Name
Implantable cardioverter defibrillator (non-CRT)
Public Device Record Key
1cf23cf9-a966-422f-9284-0e8c6eda8547
Public Version Date
July 06, 2022
Public Version Number
9
DI Record Publish Date
August 17, 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 | 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 |