Duns Number:006261481
Device Description: GDWR CGRLS300S COUGARLS 5PK 300 ST SIL
Catalog Number
-
Brand Name
COUGAR® LS
Version/Model Number
CGRLS300S
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
6cf6a577-286c-47a1-87ec-cc600704b712
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 03, 2016
Package DI Number
20643169452835
Quantity per Package
5
Contains DI Package
00643169452831
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 |