Duns Number:413819707
Device Description: Software medical device. Intended for use by professional healthcare providers as an intra Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Catalog Number
002120
Brand Name
ClarifEye
Version/Model Number
ClarifEye - 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201743
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
44bd25c7-1f5f-48b9-b9cb-85db88f9a115
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 12, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |