Duns Number:436045833
Device Description: Single use Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies A Single use Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies America.Gyrus ACMI, Inc.
Catalog Number
EMP-FBX365HS
Brand Name
Single use Surgical Optical Fiber
Version/Model Number
OFH703611
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 24, 2022
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
K180158,K180158,K180158
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
88847375-cf7c-476b-b62e-08baf7c544cc
Public Version Date
August 25, 2022
Public Version Number
5
DI Record Publish Date
March 07, 2018
Package DI Number
08033945938147
Quantity per Package
2
Contains DI Package
08033945938130
Package Discontinue Date
August 24, 2022
Package Status
Not 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 |