Duns Number:338430324
Device Description: THD Disposable Light-Scope Proctostation Kit is composed by a THD Light-Scope LED anoscope THD Disposable Light-Scope Proctostation Kit is composed by a THD Light-Scope LED anoscope and an adaptor that allow the coupling of the anoscope with a digital camera for inspection and investigation in high resolution of the anal canal. The Light-Scope LED anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field.
Catalog Number
800132
Brand Name
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
Version/Model Number
THD Disposable Light - Scope Bevelled Proctostation Kit
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
Product Code
FER
Product Code Name
Anoscope And Accessories
Public Device Record Key
e43a31a7-ffbf-4691-9893-4869d48b4e45
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 13, 2017
Package DI Number
18033737710675
Quantity per Package
10
Contains DI Package
08033737710678
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 |