Acumatch A Series 128-01-46

GUDID 10885862021762

Exactech, Inc.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 10885862021762
• NIH Device Record Key: ebdd5915-05c7-42ef-97d5-fcf18e6e7ecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumatch A Series
• Version Model Number: 128-01-46
• Catalog Number: 128-01-46
• 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: false
• Manufacturing Date: true
• 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: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862021762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000242

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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: 2015-08-10

On-Brand Devices [Acumatch A Series]

• 10885862021885: 128-01-70
• 10885862021878: 128-01-68
• 10885862021861: 128-01-66
• 10885862021854: 128-01-64
• 10885862021847: 128-01-62
• 10885862021830: 128-01-60
• 10885862021823: 128-01-58
• 10885862021816: 128-01-56
• 10885862021809: 128-01-54
• 10885862021793: 128-01-52
• 10885862021786: 128-01-50
• 10885862021779: 128-01-48
• 10885862021762: 128-01-46
• 10885862021755: 128-01-44
• 10885862021700: 124-01-70
• 10885862021694: 124-01-68
• 10885862021687: 124-01-66
• 10885862021670: 124-01-64
• 10885862021663: 124-01-62
• 10885862021656: 124-01-60
• 10885862021649: 124-01-58
• 10885862021632: 124-01-56
• 10885862021625: 124-01-54
• 10885862021618: 124-01-52
• 10885862021601: 124-01-50
• 10885862021595: 124-01-48
• 10885862021588: 124-01-46
• 10885862021106: 122-01-70
• 10885862021090: 122-01-68
• 10885862021083: 122-01-66
• 10885862021076: 122-01-64
• 10885862021069: 122-01-62
• 10885862021052: 122-01-60
• 10885862021045: 122-01-58
• 10885862021038: 122-01-56
• 10885862021021: 122-01-54
• 10885862021014: 122-01-52
• 10885862021007: 122-01-50
• 10885862020994: 122-01-48
• 10885862020987: 122-01-46
• 10885862020970: 122-01-44
• 10885862019820: 120-01-70
• 10885862019813: 120-01-68
• 10885862019806: 120-01-66
• 10885862019790: 120-01-64
• 10885862019783: 120-01-62
• 10885862019776: 120-01-60
• 10885862019769: 120-01-58
• 10885862019752: 120-01-56
• 10885862019745: 120-01-54