113-01-04

GUDID 10885862016737

BROACH, PRIMARY, SIZE 4

Exactech, Inc.

Orthopaedic broach

• Primary Device ID: 10885862016737
• NIH Device Record Key: 8dadf7b8-378b-4ff5-bd82-24b738c2490a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 113-01-04
• Catalog Number: 113-01-04
• 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	10885862016737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041906

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

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

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

Moist Heat or Steam Sterilization

[10885862016737]

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.

• 10885862144195 - EXACTECHGPS: 2026-03-19 MOUNTING ARM
• 10885862144218 - EXACTECHGPS: 2026-03-19 MOUNTING ARM CLAMP
• 10885862144225 - EXACTECHGPS: 2026-03-19 POWER CABLE
• 10885862144256 - EXACTECHGPS: 2026-03-19 PROBE
• 10885862144263 - EXACTECHGPS: 2026-03-19 TRACKER
• 10885862144270 - EXACTECHGPS: 2026-03-19 TRACKER
• 10885862144287 - EXACTECHGPS: 2026-03-19 TRACKER
• 10885862144294 - EXACTECHGPS: 2026-03-19 IMPLANT KIT