Duns Number:017134557
Device Description: SQ-RX Pulse Generator
Catalog Number
-
Brand Name
SQ-RX® PULSE GENERATOR
Version/Model Number
1010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 17, 2020
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
P110042,P110042,P110042,P110042,P110042
Product Code
LWS
Product Code Name
Implantable cardioverter defibrillator (non-CRT)
Public Device Record Key
6961efbb-5e1f-4d65-bcff-2ef6de95fa85
Public Version Date
March 19, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 9 |