Duns Number:315304071
Device Description: LOGIC HD CAMERA HEAD GREEN For fluorescence imaging with ICG dye, Snap-on locking mechani LOGIC HD CAMERA HEAD GREEN For fluorescence imaging with ICG dye, Snap-on locking mechanism, 2 chip, integrated lens f = 24mm, 2 programmable camera-head buttons, Activation/deactivation of near-infrared mode
Catalog Number
85525812
Brand Name
NA
Version/Model Number
85525812
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
K212808
Product Code
FET
Product Code Name
Endoscopic video imaging system/component, gastroenterology-urology
Public Device Record Key
e70e167c-a6ac-4000-a37b-72004d4f5774
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |