Catalog Number

104008

Brand Name

PhotonGuide

Version/Model Number

Narrow / Flat

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 25, 2022

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

4685c3f0-d5db-41e6-8b32-3b6084da7e79

Public Version Date

October 06, 2022

Public Version Number

7

DI Record Publish Date

June 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-