Duns Number:006261481
Device Description: CATH U5TRACKSHA DXT 5F 5PK 110CM TRACK
Catalog Number
-
Brand Name
DxTerity™ TRA
Version/Model Number
U5TRACKSHA
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
K161287,K161287
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
0cda652f-7702-4876-bc7d-b64279df5b43
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 19, 2017
Package DI Number
20643169739042
Quantity per Package
5
Contains DI Package
00643169739048
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 |