PhotonSaber Y ES2Y

GUDID 00816728020455

The Invuity PhotonSaber Y with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.

INVUITY, INC.

Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use
Primary Device ID00816728020455
NIH Device Record Keyf2ddb5d7-e3f4-4f49-a9de-f70b1424e007
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhotonSaber Y
Version Model NumberFin Tip
Catalog NumberES2Y
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 Identifiers

Device Issuing AgencyDevice ID
GS100816728020455 [Primary]

FDA Product Code

JOLCatheter And Tip, Suction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-24
Device Publish Date2016-09-22

On-Brand Devices [PhotonSaber Y]

00816728020462The Invuity PhotonSaber Y with Yankauer is intended to deliver illumination from a high intensit
00816728020455The Invuity PhotonSaber Y with Yankauer is intended to deliver illumination from a high intensit
00816728020448The Invuity PhotonSaber Y with Yankauer is intended to deliver illumination from a high intensit
00816728020431The Invuity PhotonSaber Y with Yankauer is intended to deliver illumination from a high intensit

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