RBK Patello Femoral GO-1003-40-00

GUDID 09340499004662

RBK Patella 40mm

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 09340499004662
• NIH Device Record Key: af5db6f8-8315-4615-b616-17870d6dcdee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RBK Patello Femoral
• Version Model Number: GO-1003-40-00
• Catalog Number: GO-1003-40-00
• 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	09340499004662 [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

On-Brand Devices [RBK Patello Femoral]

• 09340499022710: RBK Patello Femoral Size 4 Right
• 09340499022703: RBK Patello Femoral Size 4 Left
• 09340499017808: RBK Patello Femoral Size 3 Right
• 09340499017792: RBK Patello Femoral Size 3 Left
• 09340499017785: RBK Patello Femoral Size 2 Right
• 09340499017778: RBK Patello Femoral Size 2 Left
• 09340499017761: RBK Patello Femoral Size 1 Right
• 09340499017754: RBK Patello Femoral Size 1 Left
• 09340499017747: RBK Patello Femoral Size 0 Right
• 09340499017730: RBK Patello Femoral Size 0 Left
• 09340499004662: RBK Patella 40mm
• 09340499004655: RBK Patella 36mm
• 09340499004648: RBK Patella 32mm
• 09340499004631: RBK Patella 28mm