FDA.reportPublic FDA data

Integrity Sterilizers

Primary DI
10841736100063
Brand
Integrity Sterilizers
Company
SKYTRON LLC
Model
INTEGRITY 215
Catalog number
INTEGRITY 215
Device description
"Integrity 215 Vacuum/Gravity Steam Sterilizer, 21.5""W x 21.5""H x 38""D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam"
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
10841736100063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173610006310841736100063

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit
Special Storage Condition, Specify00No Condensation
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
078375583
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736125271Skytron4-040-224-040-222026-05-01
10841736125257Sterling Washers291853329185332026-04-26
10841736124441SkytronSOFPADII1-021-03-22026-04-14
10841736124458SkytronSOFPADII1-021-03-32026-04-14
10841736124465SkytronSOFPADII1-021-03-42026-04-14
10841736124472SkytronSOFPADII1-021-06-22026-04-14
10841736124489SkytronSOFPADII1-021-06-32026-04-14
10841736124496SkytronSOFPADII1-021-06-42026-04-14
10841736124502SkytronSOFPADII1-021-07-22026-04-14
10841736124519SkytronSOFPADII1-021-07-32026-04-14
10841736124526SkytronSOFPADII1-021-07-42026-04-14
10841736124533SkytronSOFPADII1-021-08-22026-04-14
10841736124540SkytronSOFPADII1-021-08-32026-04-14
10841736124557SkytronSOFPADII1-021-08-42026-04-14
10841736124564SkytronSOFPADII1-021-11-22026-04-14
10841736124571SkytronSOFPADII1-021-11-32026-04-14
10841736124588SkytronSOFPADII1-021-11-42026-04-14
10841736124595SkytronSOFPADII1-021-12-22026-04-14
10841736124601SkytronSOFPADII1-021-12-32026-04-14
10841736124618SkytronSOFPADII1-021-12-42026-04-14

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