Duns Number:083171244
Device Description: ACCUDRAIN LASERThe AccuDrain Laser Level device is provided with a mounting bracket for us ACCUDRAIN LASERThe AccuDrain Laser Level device is provided with a mounting bracket for use with Integra AccuDrain external CSF drainage systems. The AccuDrain Laser Level is an alignment tool for the AccuDrain drainage system. AccuDrain drainage systems are used for draining cerebrospinal fluid from an intraventricular catheter or lumbar catheter to an external drainage system.
Catalog Number
INS8902
Brand Name
AccuDrain®
Version/Model Number
INS8902
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K042825
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
8e983d37-db3f-4384-9d70-40ba5e3879c3
Public Version Date
October 26, 2022
Public Version Number
7
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 |