Acumatch M-Series SPI-003185

GUDID 10885862629432

Femoral Head Impactor

Exactech, Inc.

Orthopaedic implant impactor, reusable

• Primary Device ID: 10885862629432
• NIH Device Record Key: 84ec0ce5-81d5-4966-8322-6bbbeba3e03a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumatch M-Series
• Version Model Number: SPI-003185
• Catalog Number: SPI-003185
• 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	10885862629432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032964

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

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

[10885862629432]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-19
• Device Publish Date: 2023-04-11

On-Brand Devices [Acumatch M-Series]

• 10885862629432: Femoral Head Impactor