Duns Number:536935331
Device Description: The spreading forceps is used to generate compression to achieve fixation. Placed in the d The spreading forceps is used to generate compression to achieve fixation. Placed in the diamond of the staple, by squeezing the diamond will expand and the staple legs will come together in a parallel manner.
Catalog Number
-
Brand Name
LARGE UNI-CLIP®
Version/Model Number
119314ND
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
HTD
Product Code Name
FORCEPS
Public Device Record Key
ee86c40c-e316-4a58-9cae-db254b3e7ee5
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 |