Equinoxe SPI-009728

GUDID 10885862635334

Special GPS rTSA Reamer, Circular, 42mm

Exactech, Inc.

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• Primary Device ID: 10885862635334
• NIH Device Record Key: 3c6d3471-4570-408f-9a49-9ab6dfa5b51e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equinoxe
• Version Model Number: SPI-009728
• Catalog Number: SPI-009728
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862635334 [Primary]

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

[10885862635334]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01