Duns Number:058614483
Device Description: Clip Applier
Catalog Number
-
Brand Name
Premium SurgiClip III
Version/Model Number
133650
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K142869,K142869
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
0ac43dec-8127-4a6e-ab34-d16aec7e7b19
Public Version Date
September 28, 2021
Public Version Number
6
DI Record Publish Date
May 20, 2017
Package DI Number
20884521517391
Quantity per Package
6
Contains DI Package
10884521517394
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |