Acumatch L-Series BP-2840

GUDID 10885862104892

Exactech, Inc.

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 10885862104892
• NIH Device Record Key: 1e93c0e3-bef9-498a-bda8-c445da9eaff1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumatch L-Series
• Version Model Number: BP-2840
• Catalog Number: BP-2840
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862104892 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905370

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-10-30