Encore Stem Trial Neck

GUDID 09348215083182

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215083182
• NIH Device Record Key: ebf898e9-a324-4382-aa67-a5eefaf377bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encore Stem Trial Neck
• Version Model Number: 111-45-0216
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	09348215083182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211505

FDA Product Code

• HWT: Template

Sterilization

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

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

[09348215083182]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-14
• Device Publish Date: 2021-10-06

On-Brand Devices [Encore Stem Trial Neck]

• 09348215083243: 111-45-1017
• 09348215083236: 111-45-0717
• 09348215083229: 111-45-0617
• 09348215083212: 111-45-1016
• 09348215083205: 111-45-0716
• 09348215083199: 111-45-0416
• 09348215083182: 111-45-0216
• 09348215083175: 111-45-0016
• 09348215083168: 111-45-1015
• 09348215083151: 111-45-0715
• 09348215083144: 111-45-0415
• 09348215083137: 111-45-0215
• 09348215083120: 111-45-0015