Duns Number:013486803
Device Description: Disposable One-Step Trocar System, 23Ga. (3 Trocar Knives with Pre-Loaded Self-Sealing Tro Disposable One-Step Trocar System, 23Ga. (3 Trocar Knives with Pre-Loaded Self-Sealing Trocar Cannula and 1 Infusion Line)
Catalog Number
5229
Brand Name
N/A
Version/Model Number
N/A
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
NGY
Product Code Name
Cannula, Trocar, Ophthalmic
Public Device Record Key
8c51fad1-6ef3-4fed-84a1-be132578c2fa
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
April 04, 2018
Package DI Number
30818255010979
Quantity per Package
5
Contains DI Package
10818255010975
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |