Duns Number:033029433
Device Description: Rhoton Bipolar Bayonet Forceps, round handle, 1.0 mm tip, curved down, insulated, 8-5/8" ( Rhoton Bipolar Bayonet Forceps, round handle, 1.0 mm tip, curved down, insulated, 8-5/8" (22.0 cm)
Catalog Number
-
Brand Name
Novo Surgical
Version/Model Number
G1914-28I
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
ce9b8891-beeb-4668-8046-8e7e8e4b1dd1
Public Version Date
May 14, 2019
Public Version Number
1
DI Record Publish Date
May 06, 2019
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 |