Duns Number:081325959
Device Description: Radiopaque Silicone Suturable Tubing Clamps For Natus F7 Catheter
Catalog Number
NT999004
Brand Name
Natus®
Version/Model Number
NT999004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K101381,K101381,K101381
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
1f7a1161-223e-4b8e-ae79-1134c4f24c73
Public Version Date
April 13, 2020
Public Version Number
1
DI Record Publish Date
April 03, 2020
Package DI Number
00382830056175
Quantity per Package
5
Contains DI Package
00382830058148
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |