Duns Number:024328124
Device Description: Reusable Bipolar Forceps Insulated, Malis, Bayonet, 10.75" (27.3cm), 1.5mm Tip, Titanium, Reusable Bipolar Forceps Insulated, Malis, Bayonet, 10.75" (27.3cm), 1.5mm Tip, Titanium, Irrigation, Stop, Down 30
Catalog Number
-
Brand Name
STINGRAY SURGICAL PRODUCTS
Version/Model Number
S03-699TRSD30
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"
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
042faa82-e72c-4da2-82d9-1a89ed0fce0f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 2016
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 | 133 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4643 |