181-03-02

GUDID 10885862038524

ADAPTOR, LINER DRIVER, KEYED, C

Exactech, Inc.

Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable

• Primary Device ID: 10885862038524
• NIH Device Record Key: ea0616c5-7343-4de8-a740-6e9d3bb9156d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 181-03-02
• Catalog Number: 181-03-02
• 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	10885862038524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071676

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

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

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

Moist Heat or Steam Sterilization

[10885862038524]

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.

• 10885862623935 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 42mm
• 10885862623942 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 44mm
• 10885862623959 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 46mm
• 10885862623966 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 48mm
• 10885862623973 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 52mm
• 10885862623980 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 54mm
• 10885862623997 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 56mm
• 10885862624000 - EPIC: 2024-05-17 3.5mm LOCKING SCREW x 58mm