Duns Number:303655286
Device Description: Knot pusher for placing knots for laparoscopic surgery.The various Knotpushers are intende
Catalog Number
APK 001
Brand Name
A.M.I. Knotpusher Premium
Version/Model Number
APK 001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2020
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
d7dc14da-3c2b-4d5e-b085-ab9b6fa77ecd
Public Version Date
October 04, 2022
Public Version Number
2
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 |