Duns Number:033029433
Device Description: Fenestrated Dissector - 3 Piece Modular Reusable Insert, insert only, 5.0 mm sheath diamet Fenestrated Dissector - 3 Piece Modular Reusable Insert, insert only, 5.0 mm sheath diameter, double action, 17-3/4" (45.0 cm)
Catalog Number
9000-36054RM
Brand Name
Novo Surgical
Version/Model Number
9000-36054RM
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
K974382
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
0a30ef0d-5590-4502-b224-33a7817dbc2a
Public Version Date
August 21, 2019
Public Version Number
4
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 |