Duns Number:604056226
Device Description: Hemostasis Clip, Rotatable, Single-Use, Coated, 16mm (Opening) W
Catalog Number
-
Brand Name
Key Surgical Hemostasis Clips
Version/Model Number
EN10400A.16
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
eed7c0aa-a249-4d4d-89b0-1e806b338416
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
February 03, 2020
Package DI Number
10849771039225
Quantity per Package
10
Contains DI Package
00849771039228
Package Discontinue Date
-
Package Status
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 |