Duns Number:780024725
Catalog Number
03-5201
Brand Name
Flexible Video Esophagoscope (NTSC)
Version/Model Number
TNE-5000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 26, 2018
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EOX
Product Code Name
Esophagoscope (Flexible Or Rigid)
Public Device Record Key
0cfe24d9-3017-4be2-b8b2-6871adce2e0d
Public Version Date
July 02, 2019
Public Version Number
4
DI Record Publish Date
September 22, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 33 |