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
-
Brand Name
Single use Surgical Optical Fiber
Version/Model Number
EMP-FBX365HS
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
K180158,K180158,K180158
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
439e1c74-1b85-4ee7-bfe0-16eca89252f8
Public Version Date
May 07, 2021
Public Version Number
3
DI Record Publish Date
September 28, 2018
Package DI Number
08033945938710
Quantity per Package
2
Contains DI Package
08033945938574
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 |