Duns Number:089055867
Device Description: VALVE 27554-5 DELTA SM EXTRACTED PL 1.5
Catalog Number
-
Brand Name
Delta®
Version/Model Number
27554-5
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"
-
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
K951258
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
345cf28a-dbdb-4ed0-93c3-3c975f0fb6fa
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
July 01, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1465 |