189-12-13

GUDID 10885862289865

BROACH, SIZE 13

Exactech, Inc.

Orthopaedic broach

• Primary Device ID: 10885862289865
• NIH Device Record Key: 257a4e22-e003-4be1-9f40-5e8d8b63f68a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 189-12-13
• Catalog Number: 189-12-13
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862289865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140674

FDA Product Code

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

Sterilization

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

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

[10885862289865]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

Devices Manufactured by Exactech, Inc.

• 10885862566522 - Vantage: 2024-09-05 Posterior Capsule Removal Tool
• 10885862622693 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622709 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622716 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622723 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622730 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622747 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622761 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia