Super Tray

GUDID 09348215039899

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 09348215039899
• NIH Device Record Key: 28c2350b-5718-4ab2-b9d8-419fa5dccc04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Tray
• Version Model Number: 112-36-0001
• 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	09348215039899 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

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

Sterilization

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

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

[09348215039899]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-18
• Device Publish Date: 2019-05-27

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215129224 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129231 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129248 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129255 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129262 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129279 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129286 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129293 - Verteloc Lumbar Cage: 2024-03-20