Duns Number:530269083
Device Description: Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated, Full R Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated, Full Rotation wire
Catalog Number
-
Brand Name
MT
Version/Model Number
ROCC-F-26-235-C-N
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"
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
K182556,K182556,K182556
Product Code
PKL
Product Code Name
Hemostatic Metal Clip For The Gi Tract
Public Device Record Key
abad3167-2579-4cec-978f-daa5d797ef7e
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
December 31, 2021
Package DI Number
16932503530467
Quantity per Package
10
Contains DI Package
06932503530460
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |