AlloSource 11mm ProChondrix Drill/Guide

GUDID 00818614021782

Orthopaedic surgical procedure kit, non-medicated, single-use

Primary Device ID	00818614021782
NIH Device Record Key	cf0e976d-fb33-43bb-bdf2-9ed640929647
Commercial Distribution Status	In Commercial Distribution
Brand Name	AlloSource 11mm ProChondrix Drill/Guide
Version Model Number	58160-11
Company DUNS	117630237
Company Name	Maruho Medical, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00818614021782 [Primary]

LXH	Orthopedic Manual Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	true

00818614021379 - Apollo	2024-06-05 Medial Suture Anchor with Needles, PEEK
10818614022595 - Disposable Punch, 6.5 mm	2024-06-05 Disposable Punch, 6.5 mm Pouch
00818614022635 - ABS Med Distraction Pin	2023-09-06 ABS Med Distraction Pin , 12MM Pouch
10818614022649 - ABS Med Distraction Pin	2023-09-06 ABS Med Distraction Pin, 14MM Patient (Inner)
10818614021406 - Distraction Screw	2023-06-02 Distraction Screw, 12MM Patient (Inner)
10818614021413 - Distraction Screw	2023-06-02 Distraction Screw, 14MM Patient (Inner)
10818614022601 - Distraction Pin, 12MM pouch	2023-06-02 Sharp Distraction Pin, 12MM pouch
10818614022618 - Distraction Pin, 14MM pouch	2023-06-02 Sharp Distraction Pin, 14MM pouch