Duns Number:001191048
Device Description: X-Stream Laparoscopic Irrigation Tubing Set with SmokEvac Trumpet Valve, 5mm x 33cm Probe X-Stream Laparoscopic Irrigation Tubing Set with SmokEvac Trumpet Valve, 5mm x 33cm Probe Tip with Holes and Cojoined Suction/Irrigation Tubing
Catalog Number
5552000
Brand Name
X-Stream
Version/Model Number
5552000
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
2f434753-bea6-4f76-81fe-057391b895a0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 23, 2015
Package DI Number
10801741010078
Quantity per Package
5
Contains DI Package
00801741010071
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 |