Duns Number:536935331
Device Description: The impactor tip is assembled with the impactor handle with reference 119319ND. The side o The impactor tip is assembled with the impactor handle with reference 119319ND. The side of the impactor to be used is determined by the staple size.
Catalog Number
-
Brand Name
LARGE UNI-CLIP®
Version/Model Number
119321ND
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
-
Product Code
HWA
Product Code Name
IMPACTOR
Public Device Record Key
38e3ddb8-ea63-440f-80e4-fc68ec5b0328
Public Version Date
March 19, 2019
Public Version Number
3
DI Record Publish Date
May 26, 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 |