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
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
10705037043033STERRAD™99208992082018-05-31
10705037043040STERRAD™99209992092018-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23
00190776422004MillenniumAvalign Technologies, Inc.FSM2026-07-23
18059015378368Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378375Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378382Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
00841731153258ARTEMIS FUZEVILEX LLCFSM2026-07-22
00841731153265ARTEMIS TAKEDOWNVILEX LLCFSM2026-07-22
B803PW12A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW14G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW18A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW20ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW22A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW26A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW30A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW32A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW40A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW6G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
00840606195737ViaductSPINAL ELEMENTS, INC.FSM2026-07-20
00843059127478LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FSM2026-07-20
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17