FDA.reportPublic FDA data

Stryker Universal Select Sterilization Tray System

Primary DI
00857387006114
Brand
Stryker Universal Select Sterilization Tray System
Company
PARAGON MEDICAL, INC.
Model
29-13901
Device description
Upper-/Mid-Face Instrument Tray
Published
2018-04-25
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
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
00857387006114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857387006114008573870061148573870061140857387006114

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
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
00857387006213Stryker Universal Select Sterilization Tray System29-129012018-04-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653159014208CASE MEDICALCase Medical Inc.KCT2026-06-08
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00653159014239CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23