Plate Holder

GUDID 09348215066345

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: 09348215066345
• NIH Device Record Key: 2bc626a1-fe67-467b-9178-e9dd3fd8aa34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plate Holder
• Version Model Number: PS2-08-0018
• 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	09348215066345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163625

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

[09348215066345]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-03
• Device Publish Date: 2020-06-25

On-Brand Devices [Plate Holder]

• 09348215066345: PS2-08-0018
• 09348215066918: 132-16-0016