Tornier Approach YRAD105

GUDID 00846832064748

Case & Trays

TORNIER, INC.

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: 00846832064748
• NIH Device Record Key: c8deb530-4df6-4873-8e7f-f9ce9072bc00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier Approach
• Version Model Number: YRAD105
• Catalog Number: YRAD105
• Company DUNS: 968990812
• Company Name: TORNIER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832064748 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

[00846832064748]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [Tornier Approach]

• 00846832065394: Case Outer Lid
• 00846832064960: Lower Tray
• 00846832064953: Upper Tray
• 00846832064748: Case & Trays