Duns Number:303655286
Device Description: Knot pusher for placing knots when ligating haemorrhoidal arteries. Part of the A.M.I. HAL Knot pusher for placing knots when ligating haemorrhoidal arteries. Part of the A.M.I. HAL / RAR System.The various Knotpushers are intended for ligature passing and know tying.
Catalog Number
AHK 007
Brand Name
A.M.I. HAL Knotpusher
Version/Model Number
AHK 007
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
-
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
34c09d6b-9291-4c64-a964-38ef37d351c2
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 28, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |