Duns Number:103021940
Device Description: 2 PROC PACK
Catalog Number
660065AN
Brand Name
FS DISPOSABLE INTERFACE
Version/Model Number
660065AN
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
GEX
Product Code Name
Powered laser surgical instrument
Public Device Record Key
a3401372-3c86-4a36-8633-55d11a7b70d6
Public Version Date
February 26, 2020
Public Version Number
4
DI Record Publish Date
September 02, 2016
Package DI Number
15050474535302
Quantity per Package
2
Contains DI Package
05050474535305
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 3950 |