Eikon Sterilization Tray

Primary DI
00816728020233
Brand
Eikon Sterilization Tray
Company
INVUITY, INC.
Model
Narrow
Catalog number
ST1B
Device description
The Eikon Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSTLight, Surgical, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090070000INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEMInvuity, Inc.2009-04-22FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816728020233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816728020233008167280202338167280202330816728020233

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth5.2Inch
Length14Inch
Width10Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8667117768customerservice@invuity.com

Regulatory Flags#

DUNS number
175697908
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00816728020189Invuity® Fiber Optic CableSingle1100002016-09-22
00816728020219Invuity® Fiber Optic CableBifurcated1100012016-09-22
00816728020264Invuity® Sterilization TraySmall1102002016-09-22
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00816728020288Invuity® Steam Sterilization Tray1.5 x 6 x 10 in110702016-09-22
00816728020295Invuity® Steam Sterilization Tray1.5 x 10 x 15 in111852016-09-22
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00816728021605Eikon LT Adapt Smoke Evacuation135mm, Teeth RetractorA135TSE2019-08-09
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