FDA.reportPublic FDA data

Stryker Universal Select Sterilization Tray System

Primary DI
00857387006534
Brand
Stryker Universal Select Sterilization Tray System
Company
PARAGON MEDICAL, INC.
Model
29-13092
Device description
Right Angled Screwdriver Tray
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00857387006534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857387006534008573870065348573870065340857387006534

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00857387006213Stryker Universal Select Sterilization Tray System29-129012018-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094696INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094702INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094719INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094658INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094665INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094672INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094580INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094597INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094603INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094610INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094627INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094634INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094641INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00850092212009SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729267STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729274STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729281SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729298VERSAPODContainmed, Inc.KCT2026-09-29
07392532290282Astra Tech Implant System EV Surgical Tray GSDentsply Implants Manufacturing GmbHKCT2026-09-29
07392532290299Astra Tech Implant System EV Surgical TrayDentsply Implants Manufacturing GmbHKCT2026-09-29
00385640094566INSTRUSAFESummit Medical, Inc.KCT2026-09-28
00385640094573INSTRUSAFESummit Medical, Inc.KCT2026-09-28
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24