Duns Number:041546137
Device Description: Disposable One Step Trocar System 25 Ga (1 Set Of 3 Insert Handles And 1 Infusion Line), 6 Disposable One Step Trocar System 25 Ga (1 Set Of 3 Insert Handles And 1 Infusion Line), 6 Per Box
Catalog Number
12-5244
Brand Name
Rumex
Version/Model Number
12-5244
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)
-
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
2ed8eab8-1d50-40c0-b635-0f9758799f9a
Public Version Date
June 19, 2020
Public Version Number
1
DI Record Publish Date
June 11, 2020
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 | 834 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |