RBK Patella Femoral GO-1003-24-00

GUDID 09340499004624

RBK Patella 24mm

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Polyethylene patella prosthesis

• Primary Device ID: 09340499004624
• NIH Device Record Key: 10977275-988c-4d8a-8991-b56fa650526a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RBK Patella Femoral
• Version Model Number: GO-1003-24-00
• Catalog Number: GO-1003-24-00
• 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: 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

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
• 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 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	09340499004624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050473

FDA Product Code

• KRR: Prosthesis, Knee, Patello/Femoral, 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: 2021-02-05
• Device Publish Date: 2016-10-07

Devices Manufactured by GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

• 09340499005195 - GRU Tibia: 2021-07-14 GRU Tibia Size 0 6.5mm
• 09340499005201 - GRU Tibia: 2021-07-14 GRU Tibia Size 0 7.5mm
• 09340499005218 - GRU Tibia: 2021-07-14 GRU Tibia Size 0 8.5mm
• 09340499005225 - GRU Tibia: 2021-07-14 GRU Tibia Size 0 9.5mm
• 09340499005232 - GRU Tibia: 2021-07-14 GRU Tibia Size 1 6.5mm
• 09340499005249 - GRU Tibia: 2021-07-14 GRU Tibia Size 1 7.5mm
• 09340499005256 - GRU Tibia: 2021-07-14 GRU Tibia Size 1 8.5mm
• 09340499005263 - GRU Tibia: 2021-07-14 GRU Tibia Size 1 9.5mm