Duns Number:187129135
Device Description: Disposable Laparoscopic Clip Applier with 20 Clips.
Catalog Number
-
Brand Name
Epix® Universal Clip Applier
Version/Model Number
CA500
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
4f6f2fdc-8a76-4f5c-b567-b02a3fd340f3
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2015
Package DI Number
10607915125315
Quantity per Package
3
Contains DI Package
00607915125318
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 | 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 |