Duns Number:793517660
Device Description: FTS1 FloShield/Plus Tube Set is an accessory for 5mm FloShield and 10mm FloShield systems FTS1 FloShield/Plus Tube Set is an accessory for 5mm FloShield and 10mm FloShield systems and only works with these systems
Catalog Number
FTS1
Brand Name
FloShield/Plus
Version/Model Number
FTS1
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
03cd1324-aa2c-4cc2-bd87-f262f753295e
Public Version Date
April 09, 2019
Public Version Number
3
DI Record Publish Date
July 25, 2016
Package DI Number
10815128020604
Quantity per Package
6
Contains DI Package
00815128020607
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 |