Duns Number:089055867
Device Description: KIT 2120-925 INNER/ENDO SHUNT PLCMT BIO
Catalog Number
-
Brand Name
Innervision, BioGlide®
Version/Model Number
2120-925
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
K940096
Product Code
GWG
Product Code Name
ENDOSCOPE, NEUROLOGICAL
Public Device Record Key
83bac517-defe-47a2-ab97-c7de97b5384d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 21, 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 |