Omni ARCH

GUDID 00842078121023

Omni Arch Wedge System Implant/Instrument Caddy

EXTREMITY MEDICAL, LLC

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Primary Device ID	00842078121023
NIH Device Record Key	cfaf4889-16da-4312-a6e8-19604f4268aa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Omni ARCH
Version Model Number	144-10004
Company DUNS	832720358
Company Name	EXTREMITY MEDICAL, LLC
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842078121023 [Primary]

FDA Product Code

FSM	Tray, Surgical, Instrument