Bipolar Instrument Tray

GUDID 09348215038014

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray

• Primary Device ID: 09348215038014
• NIH Device Record Key: 9b4b0a2b-e07e-4cf0-b9d5-48f56fff31e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Instrument Tray
• Version Model Number: 112-24-0000
• 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	09348215038014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

Moist Heat or Steam Sterilization

[09348215038014]

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: 2019-05-27

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• 09348215027230 - Freedom Pedicle Screw System: 2024-11-07
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