Equinoxe Ergo SPI-040722

GUDID 10885862605856

Exactech, Inc.

Glenoid orthopaedic reamer

• Primary Device ID: 10885862605856
• NIH Device Record Key: 3ad449cb-1cea-4931-9c5a-eb9d8f9394b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equinoxe Ergo
• Version Model Number: SPI-040722
• Catalog Number: SPI-040722
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862605856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063569

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

[10885862605856]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-13
• Device Publish Date: 2021-09-03

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