Distraction Screw

GUDID 10818614021406

Intraoperative orthopaedic bone pin/screw, single-use

Primary Device ID	10818614021406
NIH Device Record Key	7085561d-57ba-45b9-bdc4-a80ff8c4ef53
Commercial Distribution Status	In Commercial Distribution
Brand Name	Distraction Screw
Version Model Number	909-12
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	true
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	00818614021409 [Primary]
GS1	10818614021406 [Package] Contains: 00818614021409 Package: Carton [10 Units] In Commercial Distribution

LYQ	Accessories, Fixation, Spinal Intervertebral Body

Steralize Prior To Use	false
Device Is Sterile	true

10818614021413	Distraction Screw, 14MM Patient (Inner)
10818614021406	Distraction Screw, 12MM Patient (Inner)