Duns Number:828660345
Device Description: Reusable HyProCure SinusTarsi Decompression Scissors for dissecting and cutting soft tissu Reusable HyProCure SinusTarsi Decompression Scissors for dissecting and cutting soft tissue.
Catalog Number
HYP-ST-DS
Brand Name
HYP Sinus Tarsi Decompression Scissors
Version/Model Number
11-363-11 11cm/4.5"
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
HRR
Product Code Name
Scissors, Orthopedic, Surgical
Public Device Record Key
3c18ca94-e288-4062-8c4e-dd3cae657c88
Public Version Date
September 23, 2022
Public Version Number
5
DI Record Publish Date
January 27, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |