Remedy Trial Neck

GUDID 09348215040079

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215040079
• NIH Device Record Key: c4ffc25b-cc25-4f39-a0f6-544e7f65642a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedy Trial Neck
• Version Model Number: 111-19-6254
• 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	09348215040079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• HWT: Template
• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

[09348215040079]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-18
• Device Publish Date: 2018-10-02

On-Brand Devices [Remedy Trial Neck]

• 09348215040154: 111-19-6266
• 09348215040147: 111-19-6265
• 09348215040130: 111-19-6264
• 09348215040123: 111-19-6263
• 09348215040116: 111-19-6262
• 09348215040109: 111-19-6261
• 09348215040093: 111-19-6256
• 09348215040086: 111-19-6255
• 09348215040079: 111-19-6254
• 09348215040062: 111-19-6253
• 09348215040055: 111-19-6252
• 09348215040048: 111-19-6251