Exactech SK-029428

GUDID 10885862576767

Exactech, Inc.

Orthopaedic implant impactor

• Primary Device ID: 10885862576767
• NIH Device Record Key: c4052cde-3bb9-4756-a920-ed4b712a52ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exactech
• Version Model Number: SK-029428
• Catalog Number: SK-029428
• 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	10885862576767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182502

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

[10885862576767]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-24
• Device Publish Date: 2020-09-16

On-Brand Devices [Exactech]

• 10885862206961: 142-40-93
• 10885862206954: 142-40-10
• 10885862206947: 142-40-07
• 10885862206930: 142-40-03
• 10885862206923: 142-40-00
• 10885862026941: 142-36-93
• 10885862026927: 142-36-10
• 10885862026910: 142-36-07
• 10885862026903: 142-36-03
• 10885862026897: 142-36-00
• 10885862026880: 142-32-93
• 10885862026866: 142-32-10
• 10885862026859: 142-32-07
• 10885862026842: 142-32-03
• 10885862026835: 142-32-00
• 10885862026828: 142-28-93
• 10885862026804: 142-28-10
• 10885862026798: 142-28-07
• 10885862026781: 142-28-03
• 10885862026774: 142-28-00
• 10885862026750: 142-22-10
• 10885862026743: 142-22-07
• 10885862026736: 142-22-03
• 10885862026729: 142-22-00
• 10885862009807: 100-36-95
• 10885862009791: 100-36-10
• 10885862009784: 100-36-05
• 10885862009777: 100-36-00
• 10885862009760: 100-32-95
• 10885862009753: 100-32-10
• 10885862009746: 100-32-05
• 10885862009739: 100-32-00
• 10885862009722: 100-28-95
• 10885862009685: 100-28-10
• 10885862009678: 100-28-05
• 10885862009661: 100-28-00
• 10885862009654: 100-26-95
• 10885862009647: 100-26-10
• 10885862009630: 100-26-05
• 10885862009623: 100-26-00
• 10885862009296: 100-22-08
• 10885862009289: 100-22-03
• 10885862009272: 100-22-02
• 10885862155634: 170-32-07
• 10885862155542: 170-40-07
• 10885862155535: 170-40-93