Duns Number:089055867
Device Description: SHUNT 27819 STRATA II REG BIO
Catalog Number
-
Brand Name
Strata®, BioGlide®
Version/Model Number
27819
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K060681
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
2790ea9a-05ef-4c68-8fc2-8d9ed91cd9f3
Public Version Date
October 10, 2022
Public Version Number
4
DI Record Publish Date
June 11, 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 |