Stryker Universal Select Sterilization Tray System

GUDID 00857387006091

Implant Module Lid

PARAGON MEDICAL, INC.

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID00857387006091
NIH Device Record Key0b68acb8-3705-4f38-91d6-04dd3c9efdd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameStryker Universal Select Sterilization Tray System
Version Model Number29-13941
Company DUNS609244454
Company NamePARAGON MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com
Phone1-800-225-6975
Emailinfo@paragonmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857387006091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

[00857387006091]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-09
Device Publish Date2018-04-25

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

008573870064111/2 DIN Silicone Mat
008573870064041/4 DIN Silicone Mat
008573870063982.0 HMMF Plates/Screws Module
008573870063812.0/2.3 Mini Plates Inlay, Small
008573870063742.0/2.3 Mandible Plates/Screws Module
008573870063672.0/2.3 Mandible Recon Primary Plates Inlay
008573870063502.0/2.3 Mandible Recon Plates Module
008573870063432.0/2.3 Mini Plates Inlay, Large
008573870063362.0/2.3 Mandible Plates Module
008573870063292.0/2.3 Mandible Screw Module
008573870063122.0 MP Le-Fort Plates Inlay
008573870063052.0 MP Standard Plates Inlay, Small
008573870062992.0 MP Plates/Screws Module
008573870062822.0 MP Standard Plates Inlay, Large
008573870062752.0 MP Plates Module
008573870062682.0 MP Screw Module
008573870062511.7 Orthognathic Plates Inlay
008573870062441.7 Mid-Face Malleable Plates Inlay
008573870062371.7 Mid-Face Plates Module
008573870062201.7 Mid-Face Plates/Screws Module
008573870062131.2 Orbital Plates/Mesh Module
008573870062061.2 Upper-Face Plates/Screws Module
0085738700619090° (Right Angle) Screwdriver Instrument Tray
00857387006183HMMF Instrument Tray
008573870061763-in-1 Mandible Reconstruction Bender Tray
00857387006169Mandible Reconstruction Instrument Tray
00857387006152Trocar Instrument Tray
00857387006145Mandible Fracture Instrument Tray
00857387006138MP Instrument Tray
00857387006121Orbital Floor Instrument Tray
00857387006114Upper-/Mid-Face Instrument Tray
00857387006107Plate Module
00857387006091Implant Module Lid
008573870060841/2 DIN Instrument/Accessory Tray Lid
008573870060771/4 DIN Instrument/Accessory Tray Lid
008573870060601/2 DIN Instrument/Accessory Tray
008573870060531/4 DIN Instrument/Accessory Tray
00857387006046Three Level Rack
00857387006039Two Level Rack
008573870069922.0 TMJ Concepts Screws Module – Set
00857387006985TMJ Concepts Trocar Tray
008573870069782.0 TMJ Concepts Instrumentation Tray
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