Duns Number:752219480
Device Description: GEIS Camera (General Examination Imaging System) is a handheld device that can capture med GEIS Camera (General Examination Imaging System) is a handheld device that can capture medical grade quality images and video in Full HD 1080p resolution at the touch of a button.
Catalog Number
-
Brand Name
Visionflex
Version/Model Number
VFGEISCAM1.04
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FWB
Product Code Name
Camera, Television, Surgical, Without Audio
Public Device Record Key
97682cfd-31d8-4b59-9add-3d883d11cc5f
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 2020
Package DI Number
09352527000782
Quantity per Package
1
Contains DI Package
09352527000775
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Flip box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |