Duns Number:530269083
Device Description: Open width8±1.5mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs Open width8±1.5mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the box
Catalog Number
ROCC-C-26-235-C
Brand Name
SureClip
Version/Model Number
ROCC-C-26-235-C
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
K152001,K152001,K152001
Product Code
PKL
Product Code Name
Hemostatic Metal Clip For The Gi Tract
Public Device Record Key
637a9c25-7057-43a8-95d5-5e48209388eb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 18, 2016
Package DI Number
66932503530226
Quantity per Package
25
Contains DI Package
56932503530229
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |