Duns Number:033029433
Device Description: r-type bipolar bayonet forceps, stainless steel, round handle, 0.5 mm tip, 9 3/4" (24.7 cm r-type bipolar bayonet forceps, stainless steel, round handle, 0.5 mm tip, 9 3/4" (24.7 cm)
Catalog Number
G1914-31-0.5
Brand Name
Novo Surgical Inc.
Version/Model Number
G1914-31-0.5
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
Yes
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
GEN
Product Code Name
Forceps, General & Plastic Surgery
Public Device Record Key
0c5d4aae-7933-4d95-b86e-ad746fedbde9
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 16, 2022
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 |