STERRAD™

Primary DI
10705037016570
Brand
STERRAD™
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
20250
Catalog number
20250
Device description
STERRAD™ Starter Kit (50/100S/NX)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLRSterilizer, Chemical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLRSterilizer, ChemicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103210000
K160818000
K220404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103210000TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORSAdvanced Sterilization Products2011-06-06FRG
K160818000STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products2016-09-27MLR
K220404000STERRAD NX with ALLClear TechnologyAdvanced Sterilization Products, Inc.2022-05-16MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705037016570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503701657010705037016570

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Special Storage Condition, Specify00Store in a dry area.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)783-7723complaints@aspus.jnj.com
+1(888)783-7723ASP-Complaints@asp.com

Regulatory Flags#

DUNS number
947451626
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705037071319ULTRA GI™43381433812025-12-15
10705037042999STERRAD™99204992042026-06-03
10705037043002STERRAD™99205992052018-05-31
10705037043019STERRAD™99206992062018-05-31
10705037043026STERRAD™99207992072018-05-31
10705037043033STERRAD™99208992082018-05-31
10705037043040STERRAD™99209992092018-05-31
10705037043057STERRAD™99210992102018-05-31
10705037043064STERRAD™99211992112018-05-31
20705037045553CIDEX™20392203922016-09-24
20705037045560CIDEX™20393203932016-09-24
10705037067244SEALSURE™14202NL14202NL2021-02-11
10705037048908STERRAD VELOCITY™43210432102017-10-10
10705037049400STERRAD VELOCITY™43210-3043210-302017-10-10
10705037048915STERRAD™43220432202017-10-10
10705037047628STERRAD™99239992392016-09-24
10705037047635APTIMAX™99240992402016-09-24
10705037047611APTIMAX™13839138392016-09-24
10705037015979Tyvek®12560125602025-12-18
20705037015976Tyvek®12560125602025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800066500306STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
08800066500320STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
00889024636118Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636132Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636170Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636187Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636224Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636231Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636255Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636279Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636286Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636309Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636323Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636330Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636378Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636385Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636408Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636415Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636439Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636453Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636460Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636477Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636507Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636545Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636583Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636613Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636675Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636682Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636699Trilogy®Zimmer, Inc.MLR2022-02-25
00850012210023Sterilucent™ Sterilant DiscSTERILUCENT, INC.MLR2020-04-29