Everglade Stem, Standard Offset

GUDID 09348215107130

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215107130
• NIH Device Record Key: 142b9713-8f4a-4dc4-b7e6-5b97466d7205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everglade Stem, Standard Offset
• Version Model Number: 111-45-0811
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215107130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211505

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [Everglade Stem, Standard Offset]

• 09348215107178: 111-45-1211
• 09348215107161: 111-45-1111
• 09348215107154: 111-45-1011
• 09348215107147: 111-45-0911
• 09348215107130: 111-45-0811
• 09348215107123: 111-45-0711
• 09348215107116: 111-45-0611
• 09348215107109: 111-45-0511
• 09348215107093: 111-45-0411
• 09348215107086: 111-45-0311
• 09348215107079: 111-45-0211
• 09348215107062: 111-45-0111
• 09348215107055: 111-45-0011