Duns Number:191077671
Device Description: CAT8 115 XTORQ Plus Lightning
Catalog Number
-
Brand Name
Indigo System
Version/Model Number
LITNG8XTORQ115-S
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"
Yes
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
K193244
Product Code
QEW
Product Code Name
Peripheral Mechanical Thrombectomy With Aspiration
Public Device Record Key
fa1e6a1c-8686-4f35-9c1e-315de4725df2
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
January 06, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 918 |
U | Unclassified | 1 |