Duns Number:536935331
Device Description: The LARGE UNI-CLIP STAPLE is a staple so that, by widening the diamond shaped opening, mec The LARGE UNI-CLIP STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of size (20mm or 25mm interaxis and lengths vary from 20 to 32mm). The LARGE UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered sterile.
Catalog Number
313820SND
Brand Name
Large UNI-CLIP
Version/Model Number
313820SND
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 22, 2018
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"
Yes
For Single-Use
-
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
K061594
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
824df364-aaa0-4d38-bbb8-1efdedd13458
Public Version Date
November 23, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |