151-14-12

GUDID 10885862030030

PILOT SHAFT, MILL GUIDE, METAPHYSEAL, 11mm x 165mm

Exactech, Inc.

Orthopaedic reamer guide

• Primary Device ID: 10885862030030
• NIH Device Record Key: 38af5d04-4c3d-4b66-810d-4a6ccb5dc480
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 151-14-12
• Catalog Number: 151-14-12
• 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

• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Length: 165 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862030030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010120

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

Moist Heat or Steam Sterilization

[10885862030030]

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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• 10885862653338 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 2.5
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