EXTERNAL DISTRACTION SYSTEM 01-3585

GUDID 00841036010928

Implantable craniofacial bone distractor

Primary Device ID	00841036010928
NIH Device Record Key	701b5200-2224-4212-81ac-840a4dba1e00
Commercial Distribution Status	In Commercial Distribution
Brand Name	EXTERNAL DISTRACTION SYSTEM
Version Model Number	01-3585
Catalog Number	01-3585
Company DUNS	046189866
Company Name	BIOMET MICROFIXATION, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	+1(904)741-4400
Email	FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Issuing Agency	Device ID
GS1	00841036010928 [Primary]

MQN	EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Steralize Prior To Use	true
Device Is Sterile	false

[00841036010928]

Moist Heat or Steam Sterilization