Remedy Broach

GUDID 09348215040017

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215040017
• NIH Device Record Key: a1148eb3-9049-44b2-8142-1d2af9964413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedy Broach
• Version Model Number: 111-19-6210
• 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: false
• 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	09348215040017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

[09348215040017]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-04
• Device Publish Date: 2018-10-02

On-Brand Devices [Remedy Broach]

• 09348215040031: 111-19-6212
• 09348215040024: 111-19-6211
• 09348215040017: 111-19-6210
• 09348215040000: 111-19-6209
• 09348215039998: 111-19-6208
• 09348215039981: 111-19-6207
• 09348215039974: 111-19-6206
• 09348215039967: 111-19-6205
• 09348215039950: 111-19-6204
• 09348215039943: 111-19-6203
• 09348215039936: 111-19-6202
• 09348215039929: 111-19-6201
• 09348215039912: 111-19-6200