FDA.reportPublic FDA data

STERRAD™

Primary DI
10705037069583
Brand
STERRAD™
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
43380
Device description
STERRAD™ 100NX System ULTRA GI™ Cycle Validation Kit
Published
2024-09-25
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
FRCIndicator, biological sterilization process
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234082000
K234084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234082000STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization Products2024-07-05MLR
K234084000STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)Advanced Sterilization Products, Inc.2024-07-05JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705037069583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503706958310705037069583

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
947451626
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705037048717ASP AEROFLEX™28000280002019-07-31
10705037030958EVOTECH™50004500042016-09-24
10705037048908STERRAD VELOCITY™43210432102017-10-10
10705037049400STERRAD VELOCITY™43210-3043210-302017-10-10
10705037000562EVOTECH™010460101046012018-05-31
10705037045006EVOTECH™010410101041012016-09-24
10705037016495STERRAD™20228202282016-09-24
10705037016198STERRAD™14100141002016-09-24
10705037014132STERRAD NX™10033100332016-09-24
10705037016952STERRAD™21005210052018-05-31
10705037016211Cyclesure14324143242016-09-24
10705037044580CIDEX™226622662016-09-24
10705037012602EVOTECH™8450018450012016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155123Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155161Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155178Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155185Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155192Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
06954454006672COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006689COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006696COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006702COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006719COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006726COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006733COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006740COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454013984COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
08404535038446Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-30
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23