Duns Number:006261481
Device Description: CATH 4A0069 SS 5PK 4F ANG KIT W/3D RGHT
Catalog Number
-
Brand Name
NA
Version/Model Number
4A0069
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
-
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
2bf24c29-d80e-4e7b-a982-53edfe93d89f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 12, 2016
Package DI Number
20613994803492
Quantity per Package
5
Contains DI Package
00613994803498
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 |