Eikon Sterilization Tray ST1B

GUDID 00816728020233

The Eikon Sterilization Tray is intended to allow sterilization of the enclosed medical devices.

INVUITY, INC.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00816728020233
NIH Device Record Keybe21d350-d920-4b15-813f-10c195eacb52
Commercial Distribution StatusIn Commercial Distribution
Brand NameEikon Sterilization Tray
Version Model NumberNarrow
Catalog NumberST1B
Company DUNS175697908
Company NameINVUITY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
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
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
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com

Device Dimensions

Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch
Depth5.2 Inch
Width10 Inch
Length14 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100816728020233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSTLight, Surgical, Fiberoptic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


[00816728020233]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-04-24
Device Publish Date2016-09-22

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