Duns Number:001191048
Device Description: Suction Irrigation Probe, Trumpet Valve Style with Insert Channel Non-conductive 5mm Diame Suction Irrigation Probe, Trumpet Valve Style with Insert Channel Non-conductive 5mm Diameter Tip with Side Eyes
Catalog Number
0043950
Brand Name
Suction Irrigation Probe
Version/Model Number
0043950
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
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
ab418a85-c5d6-4fad-9b14-bf189188b673
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 23, 2015
Package DI Number
10801741065238
Quantity per Package
10
Contains DI Package
00801741065231
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| 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 |