Duns Number:829951404
Device Description: Endoscopic Ligation Clip
Catalog Number
C910001
Brand Name
Padlock Clip-12
Version/Model Number
C910001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 14, 2017
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
-
Product Code
PKL
Product Code Name
Hemostatic Metal Clip For The Gi Tract
Public Device Record Key
d0742cf7-7bbc-47af-be51-b3da2b242564
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 09, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |