Precision MIS Bunion System P27-101-100R

GUDID 00889795132772

Outrigger, Right

PARAGON 28, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00889795132772
NIH Device Record Key10af402b-f3df-4dd8-94d0-86d24255599a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision MIS Bunion System
Version Model NumberP27-101-100R
Catalog NumberP27-101-100R
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795132772 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-01
Device Publish Date2024-01-24

On-Brand Devices [Precision MIS Bunion System]

00889795133083Screw Caddy Lid
00889795133076Screw Caddy Base
00889795133069Instrument Tray 2
00889795133052Instrument Tray 1
00889795133045Case Base
00889795133038Case Lid
00889795133021Curved Elevator
00889795133014Straight Elevator
00889795133007K-wire Tube, Ø4.0 Screw
00889795132994K-wire Tube, Ø3.5 Screw
00889795132987K-wire Tube, Ø3.0 Screw
00889795132970Drill Guide Tube, Medial Screw, 4.0 Drill
00889795132963Drill Guide Tube, Medial Screw, 3.5 Drill
00889795132956Drill Guide Tube, Medial Screw, 3.0 Drill
00889795132949Drill Guide Tube, Lateral Screw, 4.0 Drill
00889795132932Drill Guide Tube, Lateral Screw, 3.5 Drill
00889795132925Drill Guide Tube, Lateral Screw, 3.0 Drill
00889795132918Screw Tube, Lateral Screw, Common
00889795132901Parallel K-Wire Guide, Handled, Ø3.5 and Ø4.0 Screws
00889795132895Parallel K-Wire Guide, Handled, Ø3.0 Screw
00889795132888Drill Guide/Soft Tissue Protector (double sided), Handled, Ø4.0 Screw
00889795132871Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.5 Screw
00889795132864Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.0 Screw
00889795132857Cleaning wire
00889795132840Reduction Wire
00889795132833Freer Elevator
00889795132826Countersink, Ø4.0 Screw
00889795132819Countersink, Ø3.5 Screw
00889795132802Countersink, Ø3.0 Screw
00889795132796Angel Wing
00889795132789Outrigger, Left
00889795132772Outrigger, Right
00889795132765Depth Gauge, Common
00889795132758Sterilization Container, K-wire, Outrigger Fixation
00889795132741Sterilization Container for Ø1.7 x 230mm K-wire
00889795132734Sterilization Container for Ø1.6 x 230mm K-wire
00889795132727Sterilization Container for Ø1.2 x 230mm K-wire
00889795132710Ø1.7 x 230mm Smooth K-wire for Ø4.0 Screw
00889795132703Ø1.6 x 230mm Smooth K-wire for Ø3.5 Screw
00889795132697Ø1.2 x 230mm Smooth K-wire for Ø3.0 Screw
00889795132680K-wire, 2.0mm x 100mm
00889795132604Ø3.5 Driver, Cannulated Long
00889795132598Ø3.0 Driver, Cannulated Long
00889795132581Ø3.0mm Cannulated Drill for Ø4.0 Screw, Short
00889795132574Ø2.7mm Cannulated Drill for Ø3.5 Screw, Short
00889795132567Ø2.4mm Cannulated Drill for Ø3.0 Screw, Short
00889795132550Ø2.4mm Cannulated Drill for Ø3.0 Screw, Long
00889795132222Precision MIS Screw, Cannulated, Ø4.0 x 70mm
00889795132215Precision MIS Screw, Cannulated, Ø4.0 x 68mm
00889795132208Precision MIS Screw, Cannulated, Ø4.0 x 66mm
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