189-12-09

GUDID 10885862289827

BROACH, SIZE 9

Exactech, Inc.

Orthopaedic broach

• Primary Device ID: 10885862289827
• NIH Device Record Key: 397fae71-7a36-4b72-9a88-7ef86619c83e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 189-12-09
• Catalog Number: 189-12-09
• 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	10885862289827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140674

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

Moist Heat or Steam Sterilization

[10885862289827]

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

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• 10885862657176 - Vantage: 2025-05-20 3D+ Fork Distractor Tip – Size 3