AlloSource 20mm ProChondrix Drill/Guide

GUDID 00818614021829

Single-use disposable orthopedic manual surgical instrument

Maruho Medical, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00818614021829
NIH Device Record Key146d1125-3150-41a1-80f9-aff069f30ad5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlloSource 20mm ProChondrix Drill/Guide
Version Model Number58160-20
Company DUNS117630237
Company NameMaruho Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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 Dimensions

Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100818614021829 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-16
Device Publish Date2022-03-08

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10818614021413 - Distraction Screw2023-06-02 Distraction Screw, 14MM Patient (Inner)
10818614022601 - Distraction Pin, 12MM pouch2023-06-02 Sharp Distraction Pin, 12MM pouch
10818614022618 - Distraction Pin, 14MM pouch2023-06-02 Sharp Distraction Pin, 14MM pouch

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