Duns Number:436045833
Device Description: Reusable 10x Precision Surgical Optical Fiber ø 365 µm
Catalog Number
-
Brand Name
Reusable Surgical Optical Fiber
Version/Model Number
FSX365
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
-
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
113eb4be-8da1-48f6-a8b7-9ab216f00264
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
May 13, 2022
Package DI Number
08059173392650
Quantity per Package
5
Contains DI Package
08059173392445
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 225 |