Duns Number:793517660
Device Description: The Air Only FloShield System is a single-use, disposable laparoscopic accessory device in The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and debris deflection during minimally-invasive surgery while maintaining visualization of the surgical site.
Catalog Number
FSB-02-1045T
Brand Name
FloShield/Air
Version/Model Number
FSB-02-1045T
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
d76e16bd-913c-4f86-8dbb-e363c5723fb7
Public Version Date
April 09, 2019
Public Version Number
3
DI Record Publish Date
December 12, 2016
Package DI Number
10815128020284
Quantity per Package
6
Contains DI Package
00815128020287
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sales Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |