Duns Number:006261481
Device Description: GDWR LVCLS190S COUGRLS CRM 5PK 190 ST HY
Catalog Number
-
Brand Name
COUGAR® LS
Version/Model Number
LVCLS190S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2022
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
98f14e53-86b0-4853-a310-d90f13f6e5c2
Public Version Date
October 25, 2022
Public Version Number
5
DI Record Publish Date
August 04, 2016
Package DI Number
20643169453283
Quantity per Package
5
Contains DI Package
00643169453289
Package Discontinue Date
July 21, 2022
Package Status
Not 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 |