Duns Number:338430324
Device Description: THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, read THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required.THD Disposable comes in single packing (single use), including ligator, 4 rings, and loading system.THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger
Catalog Number
800079
Brand Name
THD Bandy
Version/Model Number
THD Bandy
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
K093497,K093497
Product Code
FHN
Product Code Name
Ligator, Hemorrhoidal
Public Device Record Key
1b2fee0a-f57d-476a-82fd-09312d3f5f11
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
18033737710682
Quantity per Package
10
Contains DI Package
08033737710685
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 |