Equinoxe 301-32-10

GUDID 10885862577535

Exactech, Inc.

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Primary Device ID	10885862577535
NIH Device Record Key	0f33a4c2-4aa5-44eb-a215-bc235bf8ce9f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Equinoxe
Version Model Number	301-32-10
Catalog Number	301-32-10
Company DUNS	157565946
Company Name	Exactech, 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	false
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862577535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162726

FDA Product Code

PHX	Shoulder Prosthesis, Reverse Configuration