Duns Number:175697908
Device Description: The PhotonGuide Adapt is intended to provide surgical site illumination from a high intens The PhotonGuide Adapt is intended to provide surgical site illumination from a high intensity light source.
Catalog Number
PGA1
Brand Name
PhotonGuide Adapt
Version/Model Number
PhotonGuide Adapt
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
7ccfc37c-0c0c-4895-b68c-e1b1fcdde69e
Public Version Date
October 13, 2021
Public Version Number
4
DI Record Publish Date
April 19, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |