Paragon GM08001-207-08

GUDID 09340499023038

Paragon Stem Standard Collared Sz 8 HA

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 09340499023038
• NIH Device Record Key: 8e49fb95-f37b-412e-8eec-9fe6381c9bb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon
• Version Model Number: GM08001-207-08
• Catalog Number: GM08001-207-08
• 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

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	09340499023038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123782

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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: 2021-07-09
• Device Publish Date: 2016-05-31

On-Brand Devices [Paragon]

• 09340499024509: Paragon Stem Inserter - Non-Threaded
• 09340499023915: Paragon Stem Coxa Vara Collared Sz 12 HA
• 09340499023908: Paragon Stem Coxa Vara Collared Sz 11 HA
• 09340499023892: Paragon Stem Coxa Vara Collared Sz 10 HA
• 09340499023885: Paragon Stem Coxa Vara Collared Sz 9 HA
• 09340499023878: Paragon Stem Coxa Vara Collared Sz 8 HA
• 09340499023861: Paragon Stem Coxa Vara Collared Sz 7 HA
• 09340499023854: Paragon Stem Coxa Vara Collared Sz 6 HA
• 09340499023847: Paragon Stem Coxa Vara Collared Sz 5 HA
• 09340499023830: Paragon Stem Coxa Vara Collared Sz 4 HA
• 09340499023823: Paragon Stem Coxa Vara Collared Sz 3 HA
• 09340499023816: Paragon Stem Coxa Vara Collared Sz 2 HA
• 09340499023809: Paragon Stem Coxa Vara Collared Sz 1 HA
• 09340499023793: Paragon Stem Coxa Vara Sz 12 HA
• 09340499023786: Paragon Stem Coxa Vara Sz 11 HA
• 09340499023779: Paragon Stem Coxa Vara Sz 10 HA
• 09340499023762: Paragon Stem Coxa Vara Sz 9 HA
• 09340499023755: Paragon Stem Coxa Vara Sz 8 HA
• 09340499023748: Paragon Stem Coxa Vara Sz 7 HA
• 09340499023731: Paragon Stem Coxa Vara Sz 6 HA
• 09340499023724: Paragon Stem Coxa Vara Sz 5 HA
• 09340499023717: Paragon Stem Coxa Vara Sz 4 HA
• 09340499023700: Paragon Stem Coxa Vara Sz 3 HA
• 09340499023694: Paragon Stem Coxa Vara Sz 2 HA
• 09340499023687: Paragon Stem Coxa Vara Sz 1 HA
• 09340499023199: Paragon Stem High Offset Collared Sz 12 HA
• 09340499023182: Paragon Stem High Offset Collared Sz 11 HA
• 09340499023175: Paragon Stem High Offset Collared Sz 10 HA
• 09340499023168: Paragon Stem High Offset Collared Sz 9 HA
• 09340499023151: Paragon Stem High Offset Collared Sz 8 HA
• 09340499023144: Paragon Stem High Offset Collared Sz 7 HA
• 09340499023137: Paragon Stem High Offset Collared Sz 6 HA
• 09340499023120: Paragon Stem High Offset Collared Sz 5 HA
• 09340499023113: Paragon Stem High Offset Collared Sz 4 HA
• 09340499023106: Paragon Stem High Offset Collared Sz 3 HA
• 09340499023090: Paragon Stem High Offset Collared Sz 2 HA
• 09340499023083: Paragon Stem High Offset Collared Sz 1 HA
• 09340499023076: Paragon Stem Standard Collared Sz 12 HA
• 09340499023069: Paragon Stem Standard Collared Sz 11 HA
• 09340499023052: Paragon Stem Standard Collared Sz 10 HA
• 09340499023045: Paragon Stem Standard Collared Sz 9 HA
• 09340499023038: Paragon Stem Standard Collared Sz 8 HA
• 09340499023021: Paragon Stem Standard Collared Sz 7 HA
• 09340499023014: Paragon Stem Standard Collared Sz 6 HA
• 09340499023007: Paragon Stem Standard Collared Sz 5 HA
• 09340499022994: Paragon Stem Standard Collared Sz 4 HA
• 09340499022987: Paragon Stem Standard Collared Sz 3 HA
• 09340499022970: Paragon Stem Standard Collared Sz 2 HA
• 09340499022963: Paragon Stem Standard Collared Sz 1 HA
• 09340499005126: Paragon Stem High Offset Sz 12 HA