Duns Number:083171244
Device Description: TUOHY NEEDLE 14g 6" for Lumbar Peritoneal ShuntA 6-inch, 14-gauge Tuohy needle used for i TUOHY NEEDLE 14g 6" for Lumbar Peritoneal ShuntA 6-inch, 14-gauge Tuohy needle used for inserting the lumbar catheter end into the subarachnoid space.
Catalog Number
NL82059S03
Brand Name
Integra Spetzler™ Lumbar Peritoneal Shunt System
Version/Model Number
NL82059S03
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
K811288
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
7d27a862-cb09-48e3-8c21-e7dee883e08a
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |