Duns Number:175697908
Device Description: The PhotonGuide is intended to provide surgical site illumination from a high intensity li The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
Catalog Number
104008
Brand Name
PhotonGuide
Version/Model Number
Narrow / Flat
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
Yes
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
-
Product Code
FSZ
Product Code Name
Light, Surgical, Carrier
Public Device Record Key
9a180a85-e00c-46e7-add3-1f004fe4dd0a
Public Version Date
August 18, 2022
Public Version Number
4
DI Record Publish Date
September 22, 2016
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |