Encore Stem Broach

GUDID 09348215064631

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215064631
• NIH Device Record Key: ffc06dc5-80eb-45d9-8aff-ee23db7f8ad2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encore Stem Broach
• Version Model Number: 111-45-1114
• 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	09348215064631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211505

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

Moist Heat or Steam Sterilization

[09348215064631]

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 Broach]

• 09348215064648: 111-45-1214
• 09348215064631: 111-45-1114
• 09348215064624: 111-45-1014
• 09348215064617: 111-45-0914
• 09348215064600: 111-45-0814
• 09348215064594: 111-45-0714
• 09348215064587: 111-45-0614
• 09348215064570: 111-45-0514
• 09348215064563: 111-45-0414
• 09348215064556: 111-45-0314
• 09348215064549: 111-45-0214
• 09348215064532: 111-45-0114
• 09348215064525: 111-45-0014