Duns Number:547654578
Device Description: This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Catalog Number
-
Brand Name
Hemorrhoidal Multi-Band Ligator with Anoscope
Version/Model Number
HM/601-5-B
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FHN
Product Code Name
Ligator, Hemorrhoidal
Public Device Record Key
7a9a96cb-ea10-489b-95f9-4d47df6f8a73
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 22, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |