Duns Number:001191048
Device Description: Nezhat-Dorsey SmokEvac Trumpet Valve, with 5mmx33cm Probe Tip with Holes, Suction Tubing, Nezhat-Dorsey SmokEvac Trumpet Valve, with 5mmx33cm Probe Tip with Holes, Suction Tubing, and Dual Spike Adapter (Series 4A)
Catalog Number
5202770
Brand Name
Nezhat-Dorsey Trumpet Valve
Version/Model Number
5202770
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
28761164-58e7-4876-8e9a-c667291bd025
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 23, 2015
Package DI Number
10801741065399
Quantity per Package
6
Contains DI Package
00801741065392
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |