Duns Number:006261481
Device Description: CATH AKUNIV604 DXT 6F 5PK ANGIO RAD KIT
Catalog Number
-
Brand Name
DxTerity™ TRA Angio-Kit
Version/Model Number
AKUNIV604
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
467851f0-5779-465a-b2d0-a38b8ea1634f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2017
Package DI Number
20643169738380
Quantity per Package
5
Contains DI Package
00643169738386
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 |