Duns Number:688154202
Device Description: It is intended for use as a diagnostic device to aid in the check and management of ocular It is intended for use as a diagnostic device to aid in the check and management of ocular diseases such as macular holes, cystoid macular edema, diabetic retinopathy, aged related macular degeneration, and so on
Catalog Number
HOCT-1
Brand Name
Optical Coherence Tomography HOCT-1
Version/Model Number
HOCT-1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OBO
Product Code Name
Tomography, Optical Coherence
Public Device Record Key
b53589b1-8c55-4b85-a85a-ba1200e5f959
Public Version Date
June 05, 2020
Public Version Number
2
DI Record Publish Date
May 10, 2019
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |