Stryker Universal Select Sterilization Tray System

GUDID 00857387006329

2.0/2.3 Mandible Screw Module

PARAGON MEDICAL, INC.

Instrument tray

• Primary Device ID: 00857387006329
• NIH Device Record Key: 9941ea1f-db68-4532-a912-bfe682096db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stryker Universal Select Sterilization Tray System
• Version Model Number: 29-23900
• Company DUNS: 609244454
• Company Name: PARAGON MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com
• Phone: 1-800-225-6975
• Email: info@paragonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857387006329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173615

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

[00857387006329]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-04-24

On-Brand Devices [Stryker Universal Select Sterilization Tray System]

• 00857387006411: 1/2 DIN Silicone Mat
• 00857387006404: 1/4 DIN Silicone Mat
• 00857387006398: 2.0 HMMF Plates/Screws Module
• 00857387006381: 2.0/2.3 Mini Plates Inlay, Small
• 00857387006374: 2.0/2.3 Mandible Plates/Screws Module
• 00857387006367: 2.0/2.3 Mandible Recon Primary Plates Inlay
• 00857387006350: 2.0/2.3 Mandible Recon Plates Module
• 00857387006343: 2.0/2.3 Mini Plates Inlay, Large
• 00857387006336: 2.0/2.3 Mandible Plates Module
• 00857387006329: 2.0/2.3 Mandible Screw Module
• 00857387006312: 2.0 MP Le-Fort Plates Inlay
• 00857387006305: 2.0 MP Standard Plates Inlay, Small
• 00857387006299: 2.0 MP Plates/Screws Module
• 00857387006282: 2.0 MP Standard Plates Inlay, Large
• 00857387006275: 2.0 MP Plates Module
• 00857387006268: 2.0 MP Screw Module
• 00857387006251: 1.7 Orthognathic Plates Inlay
• 00857387006244: 1.7 Mid-Face Malleable Plates Inlay
• 00857387006237: 1.7 Mid-Face Plates Module
• 00857387006220: 1.7 Mid-Face Plates/Screws Module
• 00857387006213: 1.2 Orbital Plates/Mesh Module
• 00857387006206: 1.2 Upper-Face Plates/Screws Module
• 00857387006190: 90° (Right Angle) Screwdriver Instrument Tray
• 00857387006183: HMMF Instrument Tray
• 00857387006176: 3-in-1 Mandible Reconstruction Bender Tray
• 00857387006169: Mandible Reconstruction Instrument Tray
• 00857387006152: Trocar Instrument Tray
• 00857387006145: Mandible Fracture Instrument Tray
• 00857387006138: MP Instrument Tray
• 00857387006121: Orbital Floor Instrument Tray
• 00857387006114: Upper-/Mid-Face Instrument Tray
• 00857387006107: Plate Module
• 00857387006091: Implant Module Lid
• 00857387006084: 1/2 DIN Instrument/Accessory Tray Lid
• 00857387006077: 1/4 DIN Instrument/Accessory Tray Lid
• 00857387006060: 1/2 DIN Instrument/Accessory Tray
• 00857387006053: 1/4 DIN Instrument/Accessory Tray
• 00857387006046: Three Level Rack
• 00857387006039: Two Level Rack
• 00857387006992: 2.0 TMJ Concepts Screws Module – Set
• 00857387006985: TMJ Concepts Trocar Tray
• 00857387006978: 2.0 TMJ Concepts Instrumentation Tray