FDA.reportPublic FDA data

Integrity Sterilizers

Primary DI
10841736100414
Brand
Integrity Sterilizers
Company
SKYTRON LLC
Model
215-CR
Catalog number
215-CR
Device description
Integrity 215 Loading and Unloading Stainless Steel Transport Cart with Docking Mechanism
Published
2016-09-19
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
FLESterilizer, steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120149000SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURASakura Seiki Co., Ltd.2012-05-08FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736100414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173610041410841736100414

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Contacts#

Phone, Email table
PhoneEmail
+1(800)759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736125257Sterling Washers291853329185332026-04-26
10841736123406Sterling M1000M1000-S208E2024-04-02
10841736123413Sterling M1000M1000-S480E2024-04-02
10841736123420Sterling M1000M1000-S208S2024-04-02
10841736123437Sterling M1000M1000-S480S2024-04-02
10841736123444Sterling M1000M1000-D208E2024-04-02
10841736123451Sterling M1000M1000-D480E2024-04-02
10841736123468Sterling M1000M1000-D208S2024-04-02
10841736123475Sterling M1000M1000-D480S2024-04-02
10841736124069Sterling P180083001732023-12-20
10841736124076Sterling P1800833004152023-12-20
10841736124083Sterling P180092000032023-12-20
10841736124090Sterling P180029182472023-12-20
10841736124106Sterling P180029028502023-12-20
10841736124113Sterling P180029186982023-12-20
10841736124120Sterling P180029183452023-12-20
10841736124137Sterling P180029188032023-12-20
10841736100308I-Series WashersI5-TCI5-TC2016-09-19
10841736100339I-Series WashersI3-DCDI3-DCD2016-09-19
10841736100346I-Series WashersI3-MISI3-MIS2016-09-19

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