Duns Number:035702151
Device Description: The Prosidio L.E. all-in-one camera system is an all-in-one camera system for rigid and fl The Prosidio L.E. all-in-one camera system is an all-in-one camera system for rigid and flexible endoscopes.
Catalog Number
LE001
Brand Name
Prosidio
Version/Model Number
L.E. All-in-one endoscopy system V1.0
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FWL
Product Code Name
Camera, Cine, Endoscopic, Without Audio
Public Device Record Key
dc66b78d-eca3-4085-92d0-87adb528c210
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 06, 2021
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 | 1 |