Duns Number:006261481
Device Description: GDWR CGRXT300S COUGARXT 5PK 300 ST SIL
Catalog Number
-
Brand Name
COUGAR® XT
Version/Model Number
CGRXT300S
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
131dd95e-2caf-4588-b535-9f7040bea7fc
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 06, 2022
Package DI Number
20763000570112
Quantity per Package
5
Contains DI Package
00763000570118
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 |