Duns Number:338430324
Device Description: The Light-Scope LED rectoscope is a disposable medical device deemed for investigation of The Light-Scope LED rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma.The Light-Scope LED rectoscope combines in a single device a magnifier lens and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field.The Light-Scope LED rectoscope is ready-to-use and it also available with an inflating included.
Catalog Number
800100
Brand Name
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
Version/Model Number
THD Light - Scope LED Medium Rectoscope with inflation bulb Not Sterile
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"
Yes
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
K121135,K121135,K121135
Product Code
FER
Product Code Name
Anoscope And Accessories
Public Device Record Key
b03255dc-72c5-494c-b047-aceb137258de
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
18033737710460
Quantity per Package
10
Contains DI Package
08033737710463
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |