Duns Number:083171244
Device Description: Line Level. This compact efficient device is used to position the drainage system such tha Line Level. This compact efficient device is used to position the drainage system such that the zero pressure point is the same elevation as the patient's Foramen of Monro or exit level of the lumbar catheter.
Catalog Number
INS8903
Brand Name
AccuDrain®
Version/Model Number
INS8903
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"
-
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
85e52ccf-49f7-4509-bf3a-344041efb7ee
Public Version Date
October 03, 2022
Public Version Number
2
DI Record Publish Date
February 16, 2022
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 |