01-019-01-0019

GUDID 10885862284402

19mm TAPERED REAMER REVISION STEM

Exactech, Inc.

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 10885862284402
• NIH Device Record Key: d1cfd9d3-a49d-4d5e-a9c3-cbbe440031aa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 01-019-01-0019
• Catalog Number: 01-019-01-0019
• 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: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862284402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150066

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

[10885862284402]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

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• 10885862622730 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622747 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622761 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia