Duns Number:013486803
Device Description: Disposable One-Step Trocar System, 25Ga. (4 insert handles with preloaded trocars & 1 infu Disposable One-Step Trocar System, 25Ga. (4 insert handles with preloaded trocars & 1 infusion line)
Catalog Number
5150
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
bfb363a5-a280-40a1-a254-c3940a0045ea
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
April 04, 2018
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |