Origin DAA Stem, High Offset

GUDID 09348215036416

SIGNATURE ORTHOPAEDICS PTY LTD

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• Primary Device ID: 09348215036416
• NIH Device Record Key: db3f4333-3ad3-4931-9bdc-9848b7bd505e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin DAA Stem, High Offset
• Version Model Number: 111-39-1303
• 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	09348215036416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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 [Origin DAA Stem, High Offset]

• 09348215088569: 111-39-1813
• 09348215088545: 111-39-1613
• 09348215088521: 111-39-1513
• 09348215088507: 111-39-1413
• 09348215088484: 111-39-1313
• 09348215088460: 111-39-1213
• 09348215088446: 111-39-1113
• 09348215088422: 111-39-1013
• 09348215088408: 111-39-0913
• 09348215088385: 111-39-0813
• 09348215036454: 111-39-1803
• 09348215036447: 111-39-1603
• 09348215036430: 111-39-1503
• 09348215036423: 111-39-1403
• 09348215036416: 111-39-1303
• 09348215036409: 111-39-1203
• 09348215036393: 111-39-1103
• 09348215036386: 111-39-1003
• 09348215036379: 111-39-0903
• 09348215036362: 111-39-0803