Duns Number:627879687
Device Description: The Padlock Clip Pro-select is used in flexible endoscopy for the compression of tissue in The Padlock Clip Pro-select is used in flexible endoscopy for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Catalog Number
C913131
Brand Name
Padlock Clip Pro-Select
Version/Model Number
C913131
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
K120814,K180689,K120814,K180689
Product Code
PKL
Product Code Name
Hemostatic metal clip for the GI tract
Public Device Record Key
a04e72a3-b859-4ff4-ac1d-a5a47b796432
Public Version Date
April 07, 2021
Public Version Number
9
DI Record Publish Date
November 03, 2017
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |