Duns Number:002348191
Device Description: 8 Fr. Catheter Clamp with Fastener
Catalog Number
CC-00008
Brand Name
ARROW
Version/Model Number
IPN032959
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"
Yes
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
KGZ
Product Code Name
ACCESSORIES, CATHETER
Public Device Record Key
a3a9d58d-dee1-4d0a-9e23-f63d37c8285a
Public Version Date
July 22, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902003356
Quantity per Package
25
Contains DI Package
00801902003355
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |