Equinoxe 321-05-01

GUDID 10885862087102

GLENOID REAMER, STARTER, REVERSE SHOULDER

Exactech, Inc.

Glenoid orthopaedic reamer

• Primary Device ID: 10885862087102
• NIH Device Record Key: 0b501bf9-6d72-4fd4-87b4-fa2d6a1d3819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equinoxe
• Version Model Number: 321-05-01
• Catalog Number: 321-05-01
• 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	10885862087102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042021

FDA Product Code

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

Sterilization

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

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

[10885862087102]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-05
• Device Publish Date: 2022-07-28