PhotonGuide 102521

GUDID 00816728020066

The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.

INVUITY, INC.

Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light
Primary Device ID00816728020066
NIH Device Record Key6f1bff8d-d666-44f3-8238-3d0859b856f2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhotonGuide
Version Model NumberWide / Angled
Catalog Number102521
Company DUNS175697908
Company NameINVUITY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100816728020066 [Primary]
GS100816728020653 [Primary]

FDA Product Code

FSZLight, Surgical, Carrier

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-24
Device Publish Date2016-09-22

On-Brand Devices [PhotonGuide]

00816728020097The PhotonGuide is intended to provide surgical site illumination from a high intensity light so
00816728020080The PhotonGuide is intended to provide surgical site illumination from a high intensity light so
00816728020073The PhotonGuide is intended to provide surgical site illumination from a high intensity light so
00816728020066The PhotonGuide is intended to provide surgical site illumination from a high intensity light so

Trademark Results [PhotonGuide]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PHOTONGUIDE
PHOTONGUIDE
87017744 5210746 Live/Registered
INVUITY, INC.
2016-04-28
PHOTONGUIDE
PHOTONGUIDE
76281415 2532162 Dead/Cancelled
POLY-OPTICAL PRODUCTS, INC.
2001-07-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.