140-28-00

GUDID 10885862025395

Exactech, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 10885862025395
• NIH Device Record Key: 22e1ba2d-08e2-4fc8-80cb-cc8fb9e9a44b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 140-28-00
• Catalog Number: 140-28-00
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862025395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032964

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2014-09-01

Devices Manufactured by Exactech, Inc.

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• 10885862654793 - Equinoxe: 2024-12-02 Ergo GPS 3.2mm Drill Guide
• 10885862607324 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607331 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607348 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607355 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607362 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607379 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes