Duns Number:089055867
Device Description: ADAPTER 5196-903 STORZ USE W 5196-001
Catalog Number
-
Brand Name
Endoscope Storz Light Cable Adapter
Version/Model Number
5196-903
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
-
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
K010341
Product Code
GWG
Product Code Name
ENDOSCOPE, NEUROLOGICAL
Public Device Record Key
68d77e99-ff7b-4473-acc7-bb7d886b3d34
Public Version Date
March 19, 2021
Public Version Number
4
DI Record Publish Date
June 13, 2016
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 |