181-03-02

GUDID 10885862038524

ADAPTOR, LINER DRIVER, KEYED, C

Exactech, Inc.

Orthopaedic implant/instrument 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.

• 10885862658159 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +0, 12/14
• 10885862658166 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +3, 12/14
• 10885862658173 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +7, 12/14
• 10885862658180 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +10, 12/14
• 10885862658197 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +0, 12/14
• 10885862658203 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +3.5, 12/14
• 10885862658210 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +7, 12/14
• 10885862658227 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +10, 12/14