Duns Number:239505063
Device Description: Fairley Laser Suction 12cm Extended Tip Fairley Laser Suction 12cm Extended Tip
Catalog Number
S285
Brand Name
Single Use Surgical Professional
Version/Model Number
S285
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
2fa5d9f2-e61c-4cc0-bdd7-b255cc4c3a58
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
August 09, 2016
Package DI Number
05055299103579
Quantity per Package
4
Contains DI Package
05055299103944
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |