Duns Number:042823948
Device Description: White Sizing Catheter
Catalog Number
N5.0-35-90-P-10S-PIG-WSC-MCVA-100893-01
Brand Name
Cook
Version/Model Number
G47299
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 11, 2020
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
K162448,K162448
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
7516d137-d8b4-416f-ab19-5c95e9bce457
Public Version Date
March 12, 2020
Public Version Number
2
DI Record Publish Date
February 06, 2020
Package DI Number
10827002472997
Quantity per Package
5
Contains DI Package
00827002472990
Package Discontinue Date
March 11, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |