Duns Number:315121009
Device Description: Large EUROPCLIPS, 6 titanium clips per cartridge, 20 cartridges per box
Catalog Number
AI74CL6
Brand Name
EUROPCLIP
Version/Model Number
AI74CL6
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"
-
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
K111930,K111930
Product Code
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
2d66b1bf-5a04-4261-a065-3ac649d8b978
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
February 13, 2017
Package DI Number
07640140220000
Quantity per Package
576
Contains DI Package
04250302234160
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |