Duns Number:604056226
Device Description: Hemostasis Clip, Rotatable, Single-Use, Coated, 11mm (Opening) W
Catalog Number
-
Brand Name
Key Surgical Hemostasis Clips
Version/Model Number
EN10400A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 14, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172727,K172727,K172727
Product Code
PKL
Product Code Name
Hemostatic Metal Clip For The Gi Tract
Public Device Record Key
fc2ec855-76af-4971-b714-62447cf5ee99
Public Version Date
June 14, 2022
Public Version Number
5
DI Record Publish Date
February 03, 2020
Package DI Number
10849771039195
Quantity per Package
10
Contains DI Package
00849771039198
Package Discontinue Date
June 08, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |