Duns Number:362747011
Device Description: The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide fie The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographicand biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging ofposterior ocular structures.
Catalog Number
-
Brand Name
PLEX Elite
Version/Model Number
9000
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161194
Product Code
OBO
Product Code Name
Tomography, Optical Coherence
Public Device Record Key
2353f26a-f8ce-4767-a1d5-5fef23030d0e
Public Version Date
October 26, 2018
Public Version Number
3
DI Record Publish Date
April 14, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |