Duns Number:338430324
Device Description: THD Surgy is a versatile instrument for multiple applications in proctology.Its compact de THD Surgy is a versatile instrument for multiple applications in proctology.Its compact design allows an easy access to the anus, thus a good dilatation and a gentile retraction of the mucosa, without any trauma to the sphincter. The wide lateral slit allows an optimal visualization of the anal canal and enhanced the operative field.THD Surgy anoscope is the ideal device for all the diagnostic and operative needs in proctology, such as assessment and treatment of all proctological conditions, including haemorrhoids, fistulas, condylomas, polyps, low cancers, etc.
Catalog Number
800005
Brand Name
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
Version/Model Number
THD Surgy Maxi_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,K121135,K121135
Product Code
FER
Product Code Name
Anoscope And Accessories
Public Device Record Key
22f1f446-7118-4361-afae-ac907f80121d
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
December 23, 2016
Package DI Number
38033737710334
Quantity per Package
3
Contains DI Package
18033737710330
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 |