Duns Number:006261481
Device Description: CATHETER Z26JR355 Z2 6F 5PK 100 JR35
Catalog Number
-
Brand Name
Z2
Version/Model Number
Z26JR355
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 02, 2017
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
K010579,K010579
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
f9545818-e5e9-4fc0-8d38-b57b067e1a5c
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
June 11, 2016
Package DI Number
20613994845294
Quantity per Package
5
Contains DI Package
00613994845290
Package Discontinue Date
August 02, 2017
Package Status
Not 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 |