Duns Number:338430324
Device Description: THD Light-Scope anoscope is a disposable medical device deemed for investigation of the an THD Light-Scope anoscope is a disposable medical device deemed for investigation of the anal canal. The handle has a lodgment for a THD Fiber Optic Cable tip for using the anoscope with a THD light source. The THD Light-Scope anoscope has a flat white end which allows to reflect the light and have a clear and detailed vision of the inspected field. The THD Light-Scope anoscope can be available with truncated or bevelled tip.
Catalog Number
800115
Brand Name
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
Version/Model Number
THD Light - Scope Truncated Anoscope 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
Product Code
FER
Product Code Name
Anoscope And Accessories
Public Device Record Key
f574ad6d-480c-4314-88d1-3082f0f2119d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 23, 2016
Package DI Number
18033737710521
Quantity per Package
10
Contains DI Package
08033737710524
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 |