Duns Number:006261481
Device Description: GDWR LVCXT190J COUGARXT CRM 5PK 190 J HY
Catalog Number
-
Brand Name
COUGAR® XT
Version/Model Number
LVCXT190J
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
K140695,K140695
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
6f6a4b82-73c4-4412-b306-051f29f77e6c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 04, 2016
Package DI Number
20643169453290
Quantity per Package
5
Contains DI Package
00643169453296
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |