Eikon LT Adapt Smoke Evacuation A135WSE

GUDID 00816728021162

Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

INVUITY, INC.

Fibreoptic retractor handle
Primary Device ID00816728021162
NIH Device Record Key4a496fbd-74ca-4353-8706-ed2bdce944b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEikon LT Adapt Smoke Evacuation
Version Model Number135mm, Wide Retractor
Catalog NumberA135WSE
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+0118002533210
Emailinst.stryker.cs@stryker.com
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx

Device Dimensions

Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter
Length135 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816728021162 [Direct Marking]
GS100816728021438 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

[00816728021162]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-24
Device Publish Date2019-10-07

On-Brand Devices [Eikon LT Adapt Smoke Evacuation]

30816728021569Intended to provide tissue retraction and surgical site illumination from a high intensity light
30816728021552Intended to provide tissue retraction and surgical site illumination from a high intensity light
30816728021545Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021063Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021254Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021247Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021636Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021216Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021209Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021629Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021612Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021179Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021162Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021605Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021599Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021131Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021124Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021582Intended to provide tissue retraction and surgical site illumination from a high intensity light
00816728021575Intended to provide tissue retraction and surgical site illumination from a high intensity light
30816728021538Intended to provide tissue retraction and surgical site illumination from a high intensity light
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