Duns Number:542984702
Device Description: The Max OD. of insertion part is 2.6mm. Opening Span is 16mm. Working length 2300mm with The Max OD. of insertion part is 2.6mm. Opening Span is 16mm. Working length 2300mm with plastic covered. Rotatable. Open and close repeatedly.
Catalog Number
AG6.510E.4403.000.Z
Brand Name
NA
Version/Model Number
AG-5104-2300-090-16
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)
Yes
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,K172727,K172727
Product Code
PKL
Product Code Name
Hemostatic Metal Clip For The Gi Tract
Public Device Record Key
65386cc5-8057-4cbe-bbdf-86f5d14c7eba
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 28, 2018
Package DI Number
26959664904194
Quantity per Package
5
Contains DI Package
16959664904197
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |