GRU Femur GRU-RL/LM-2F-C

GUDID 09340499005454

GRU Femur RLLM Size 2

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Uncoated unicondylar knee femur prosthesis

• Primary Device ID: 09340499005454
• NIH Device Record Key: 1f727cd6-a028-4d2f-859a-5a3e37a519a3
• Commercial Distribution Discontinuation: 2021-07-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GRU Femur
• Version Model Number: GRU-RL/LM-2F-C
• Catalog Number: GRU-RL/LM-2F-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	09340499005454 [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