Duns Number:187129135
Device Description: Kit Contains:CFS02, 5x100 Kii SLEEVE ADVFIX 12/BXCD003, 5mm RETRIEVAL SYSTEM, 10/BXCA500, Kit Contains:CFS02, 5x100 Kii SLEEVE ADVFIX 12/BXCD003, 5mm RETRIEVAL SYSTEM, 10/BXCA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BXCTF12, 5x100 Kii Fios ZTHR DP 10/BX
Catalog Number
-
Brand Name
AME STANDARD KIT 44
Version/Model Number
GK258
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
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
-
Product Code
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
ecded561-699c-4ffb-acae-a89c7f16e09b
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 09, 2015
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 | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |