Duns Number:793517660
Device Description: The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory devi The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site. This is a convenience kit containing one Robotic FloShield/Plus sheath assembly and one Robotic FloShield/Plus tube set assembly.
Catalog Number
FSR-05-8530AU
Brand Name
Robotic FloShield/Plus
Version/Model Number
FSR-05-8530AU
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"
Yes
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
b11cafcc-1e84-4460-88e1-8aa4f2c9f6ac
Public Version Date
April 09, 2019
Public Version Number
3
DI Record Publish Date
July 29, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |