Duns Number:338430324
Device Description: The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal.The THD N-ano 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.The THD N-ano anoscope is ready-to-use and does not need for other tools.
Catalog Number
800165
Brand Name
THD N-ano anoscope
Version/Model Number
Anoscope N-Ano MAXI Truncated
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
K133687,K133687,K133687
Product Code
FER
Product Code Name
Anoscope And Accessories
Public Device Record Key
90947f27-2e3d-4459-beb5-115148dcd01a
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 12, 2018
Package DI Number
28033737710719
Quantity per Package
50
Contains DI Package
08033737710715
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cartoon Box
| 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 |