Equinoxe 313-25-41

GUDID 10885862252364

RESURFACING HEAD REAMER, 41mm

Exactech, Inc.

Humeral head prosthesis trial, reusable

• Primary Device ID: 10885862252364
• NIH Device Record Key: ac9b18e9-4c66-4116-8539-4dcc76bb31c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equinoxe
• Version Model Number: 313-25-41
• Catalog Number: 313-25-41
• 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 Dimensions

• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter
• Outer Diameter: 41 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862252364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131298

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

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

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

[10885862252364]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18