Duns Number:536935331
Device Description: The UNI-CLIP STAPLE is designed so that, by widening the diamond shaped opening, mechanica The UNI-CLIP STAPLE is designed 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 sizes (11, 12, 13 or 15mm interaxis, and lengths vary from 13 to 20mm). The UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered non sterile.
Catalog Number
213113ND
Brand Name
UNI-CLIP
Version/Model Number
213113ND
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"
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
K011716,K991482
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
38ad3ec6-1d06-481f-ac3b-8fa20827ea5e
Public Version Date
January 27, 2022
Public Version Number
4
DI Record Publish Date
October 09, 2017
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 |