STERRAD™

Primary DI
10705037016501
Brand
STERRAD™
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
20229
Catalog number
20229
Device description
STERRAD™ 100NX Validation Kit
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071537000
K092755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071537000STERRAD 100NX TEST PACKAdvanced Sterilization Products2007-12-18FRC
K092755000STERRAAD 100NX EXPRESS CYCLE TEST PACKAdvanced Sterilization Products2011-02-25FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705037016501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503701650110705037016501

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
10705037068753ASP AEROFLEX™911902891190282022-10-25
10705037047611APTIMAX™13839138392016-09-24
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
10705037015979Tyvek®12560125602025-12-18