FDA.reportPublic FDA data

Sterrad

Primary DI
20705037014658
Brand
Sterrad
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
10118
Catalog number
10118
Device description
Sterrad 200 Cassette
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLFSterilizer, ethylene-oxide gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLFSterilizer, Ethylene-Oxide GasGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705037014658PackageGS15Not in Commercial Distribution
10705037014651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503701465820705037014658
1070503701465110705037014651

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide device sterilantA gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
947451626
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10705037015924Tyvek®12544125442025-12-17
10705037015948Tyvek®12557125572025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060485030706AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115VANDERSEN STERILIZERS INC.FLF2023-08-31
05060485030713AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2023-08-31
05060485030744AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230VANDERSEN STERILIZERS INC.FLF2023-08-31
10705037067244SEALSURE™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2021-02-11
007073877870113M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877870283M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877875613M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877875783M™ Steri-Vac™3M COMPANYFLF2020-10-22
05060485030607Anprolene AN75 Ethylene Oxide SterilizerANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030614Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030621Anprolene AN75 Ethylene Oxide Sterilizer, 115VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030638Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030669Anprolene AN75 Refill Kit, 14 UnitsANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030164 EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030331AN1071 HumidichipANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030393EOGas 4 Ethylene Oxide Gas SterilizerANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030409EOGas 4 Ethylene Oxide Gas SterilizerANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030416EOGas 4 Sterilization BagANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030430AN1071 HumidichipANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030447EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030454EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
10705037014583STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
10705037014651SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
10705037014460SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
50707387767247Steri-Vac™3M COMPANYFLF2016-09-24
50707387767254Steri-Vac™3M COMPANYFLF2016-09-24
50707387767261Steri-Vac™3M COMPANYFLF2016-09-24
50707387767278Steri-Vac™3M COMPANYFLF2016-09-24
00724995152017Amsco EagleSteris Mexico, S. de R.L. de C.V.FLF2016-09-14
50724995010336EnvirosystemsSTERIS CORPORATIONFLF2016-09-08