Equinoxe 320-06-38

GUDID 10885862563699

Exactech, Inc.

Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head Reverse shoulder prosthesis head

Primary Device ID	10885862563699
NIH Device Record Key	b1658d52-96cf-4045-9252-669bcc14e793
Commercial Distribution Status	In Commercial Distribution
Brand Name	Equinoxe
Version Model Number	320-06-38
Catalog Number	320-06-38
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	true
Lot Batch	false
Serial Number	true
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862563699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K193098

FDA Product Code

PHX	Shoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-09-21
Device Publish Date	2020-09-13

On-Brand Devices [Equinoxe]

Trademark Results [Equinoxe]

Mark Image Registration \| Serial	Company Trademark Application Date
EQUINOXE 76533714 3121160 Live/Registered	Exactech, Inc. 2003-07-31
EQUINOXE 74669086 2299128 Dead/Cancelled	Caran d'Ache SA 1995-05-02
EQUINOXE 74551690 2021609 Dead/Cancelled	EQUINOXE 1994-07-20
EQUINOXE 74284084 1822644 Dead/Cancelled	C.M.S. MUSIC INC. 1992-06-12
EQUINOXE 74283205 1831282 Dead/Cancelled	C.M.S. MUSIC INC. 1992-06-09
EQUINOXE 73828780 1606586 Dead/Cancelled	ETABLISSEMENTS DE LOISY & GELET 1989-10-02
EQUINOXE 73734775 1550376 Live/Registered	ETABLISSEMENTS DE LOISY & GELET 1988-06-17
EQUINOXE 73716743 1535166 Dead/Cancelled	ALLIA 1988-03-14
EQUINOXE 73285261 1248395 Dead/Cancelled	Lainiere de Roubaix 1980-11-10