Duns Number:078410514
Device Description: The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Catalog Number
100-200
Brand Name
Amsel Occluder Device
Version/Model Number
100-200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K140932,K140932,K140932,K140932
Product Code
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
417e7f0c-8fb7-46a6-851a-9f010ab26196
Public Version Date
May 19, 2021
Public Version Number
5
DI Record Publish Date
May 26, 2017
Package DI Number
10857774006007
Quantity per Package
1
Contains DI Package
00857774006000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Single Box