FDA.reportPublic FDA data

Stryker Universal Select Sterilization Tray System

Primary DI
00857387006244
Brand
Stryker Universal Select Sterilization Tray System
Company
PARAGON MEDICAL, INC.
Model
29-17902
Device description
1.7 Mid-Face Malleable Plates Inlay
Published
2018-04-24
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
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173615000Stryker Universal Select Sterilization Tray SystemParagon Medical2018-04-18KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857387006244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857387006244008573870062448573870062440857387006244

GMDN Terms#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-225-6975info@paragonmedical.com

Regulatory Flags#

DUNS number
609244454
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857387006534Stryker Universal Select Sterilization Tray System29-130922026-05-26
00857387006541Stryker Universal Select Sterilization Tray System29-139132026-05-26
00857387006039Stryker Universal Select Sterilization Tray System29-139002018-04-25
00857387006046Stryker Universal Select Sterilization Tray System29-139102018-04-25
00857387006053Stryker Universal Select Sterilization Tray System29-139202018-04-25
00857387006060Stryker Universal Select Sterilization Tray System29-139302018-04-25
00857387006077Stryker Universal Select Sterilization Tray System29-139212018-04-25
00857387006084Stryker Universal Select Sterilization Tray System29-139312018-04-25
00857387006091Stryker Universal Select Sterilization Tray System29-139412018-04-25
00857387006107Stryker Universal Select Sterilization Tray System29-139402018-04-25
00857387006114Stryker Universal Select Sterilization Tray System29-139012018-04-25
00857387006121Stryker Universal Select Sterilization Tray System29-139022018-04-25
00857387006138Stryker Universal Select Sterilization Tray System29-139032018-04-25
00857387006145Stryker Universal Select Sterilization Tray System29-139042018-04-25
00857387006152Stryker Universal Select Sterilization Tray System29-139052018-04-25
00857387006169Stryker Universal Select Sterilization Tray System29-139062018-04-25
00857387006176Stryker Universal Select Sterilization Tray System29-139072018-04-25
00857387006183Stryker Universal Select Sterilization Tray System29-139082018-04-25
00857387006190Stryker Universal Select Sterilization Tray System29-139092018-04-25
00857387006206Stryker Universal Select Sterilization Tray System29-129002018-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817766026355X-Series CaseTecometKCT2026-09-04
00817766026362X-Series CaseTecometKCT2026-09-04
00817766026379X-Series CaseTecometKCT2026-09-04
00817766026386X-Series CaseTecometKCT2026-09-04
00817766026393X-Series CaseTecometKCT2026-09-04
00817766026430X-Series CaseTecometKCT2026-09-04
00817766026447X-Series CaseTecometKCT2026-09-04
00385640094146INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094153INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094160INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094177INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094139INSTRUSAFESummit Medical, Inc.KCT2026-08-26
00724995234232V. MuellerSteris CorporationKCT2026-08-26
00724995234249V. MuellerSteris CorporationKCT2026-08-26
00724995234256V. MuellerSteris CorporationKCT2026-08-26
00724995234263V. MuellerSteris CorporationKCT2026-08-26
00724995234270V. MuellerSteris CorporationKCT2026-08-26
00724995234287V. MuellerSteris CorporationKCT2026-08-26
00724995234294V. MuellerSteris CorporationKCT2026-08-26
00724995234300V. MuellerSteris CorporationKCT2026-08-26
00724995234317V. MuellerSteris CorporationKCT2026-08-26
00724995234324V. MuellerSteris CorporationKCT2026-08-26
00724995234331V. MuellerSteris CorporationKCT2026-08-26
00724995234348V. MuellerSteris CorporationKCT2026-08-26
00724995234355V. MuellerSteris CorporationKCT2026-08-26
00724995234362V. MuellerSteris CorporationKCT2026-08-26
00724995234379V. MuellerSteris CorporationKCT2026-08-26
00724995234386V. MuellerSteris CorporationKCT2026-08-26
00724995234393V. MuellerSteris CorporationKCT2026-08-26
00724995234409V. MuellerSteris CorporationKCT2026-08-26