GRU Femur GRU-RM/LL-0F-C

GUDID 09340499005492

GRU Femur RMLL Size 0

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis Uncoated unicondylar knee femur prosthesis

• Primary Device ID: 09340499005492
• NIH Device Record Key: 11beaf99-63c3-42b1-b342-5309bbc9bc78
• Commercial Distribution Discontinuation: 2021-07-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GRU Femur
• Version Model Number: GRU-RM/LL-0F-C
• Catalog Number: GRU-RM/LL-0F-C
• Company DUNS: 752039982
• Company Name: GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au
• Phone: +6128870100
• Email: info@globalortho.com.au

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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	09340499005492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051721

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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: 2021-07-14
• Device Publish Date: 2016-03-09

On-Brand Devices [GRU Femur]

• 09340499005546: GRU Femur RMLL Size 5
• 09340499005539: GRU Femur RMLL Size 4
• 09340499005522: GRU Femur RMLL Size 3
• 09340499005515: GRU Femur RMLL Size 2
• 09340499005508: GRU Femur RMLL Size 1
• 09340499005492: GRU Femur RMLL Size 0
• 09340499005485: GRU Femur RLLM Size 5
• 09340499005478: GRU Femur RLLM Size 4
• 09340499005461: GRU Femur RLLM Size 3
• 09340499005454: GRU Femur RLLM Size 2
• 09340499005447: GRU Femur RLLM Size 1
• 09340499005430: GRU Femur RLLM Size 0