Duns Number:047644935
Device Description: Medium Large Clips - 1 Cartridge/1 Pouch
Catalog Number
50120-ML
Brand Name
Mediflex Medi-Clip
Version/Model Number
50120-ML
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091060,K091060,K091060
Product Code
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
b197d6af-7220-4dd5-a574-6f3241593612
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
May 12, 2017
Package DI Number
30842102105013
Quantity per Package
20
Contains DI Package
20842102105016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 882 |
2 | A medical device with a moderate to high risk that requires special controls. | 595 |