FDA.reportPublic FDA data

STERRAD™

Primary DI
10705037047628
Brand
STERRAD™
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
99239
Catalog number
99239
Device description
STERRAD™ Instrument Tray Mat Kit
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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705037047625PackageGS11In Commercial Distribution
10705037047628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503704762520705037047625
1070503704762810705037047628

GMDN Terms#

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

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
00850045406615clamp-itGeneral Hospital Supply CorpFSM2026-10-01
00190776434588MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776434595MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776435899MillenniumAvalign Technologies, Inc.FSM2026-09-30
16931918122397AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918176680AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918191614AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
00888867504059Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504066Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504073Arthrex®ARTHREX, INC.FSM2026-09-21
00749756400800DeRoyalDEROYAL INDUSTRIES, INC.FSM2026-09-18
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
10888857252820DENALI® Spinal SystemVB Spine LLCFSM2026-08-28
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
10888857596740NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596757NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596764NAPA Access SystemVB Spine LLCFSM2026-07-31