Duns Number:033029433
Device Description: Titanium Bipolar Bayonet Forceps, (malis type) flat handles, 8-3/4" (22.5 cm), 0.5 mm angl Titanium Bipolar Bayonet Forceps, (malis type) flat handles, 8-3/4" (22.5 cm), 0.5 mm angled down tip, non-insulated
Catalog Number
0801-04
Brand Name
Novo Surgical
Version/Model Number
0801-04
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"
-
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
ce09d18f-ff3a-4ed9-92d9-1e29a36e353e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2724 |