01-007-20-0004

GUDID 10885862553201

STRT THRD CUP IMPTR

Exactech, Inc.

Orthopaedic implant impactor

• Primary Device ID: 10885862553201
• NIH Device Record Key: 5522b83e-e3d0-41dd-926e-ad8fa5aadb70
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 01-007-20-0004
• Catalog Number: 01-007-20-0004
• 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	10885862553201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182502

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

Moist Heat or Steam Sterilization

[10885862553201]

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

Devices Manufactured by Exactech, Inc.

• 10885862653109 - Alteon: 2024-12-02 Special Anterior Approach Cip Impactor Alignment Guide
• 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