General 86-9923

GUDID 10889981159474

TruProfile Plate Caddy

SEASPINE ORTHOPEDICS CORPORATION

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

• Primary Device ID: 10889981159474
• NIH Device Record Key: 17f92028-dcfb-4a9a-a50b-2225610d6d06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General
• Version Model Number: 86-9923
• Catalog Number: 86-9923
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981159474 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211903

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

[10889981159474]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-11
• Device Publish Date: 2021-10-02

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• 10889981144296: Palm Style Probe
• 10889981144265: 3.5mm Tap File
• 10889981143497: Dilator 5 Threaded File
• 10889981140267: Locking Driver, Free Sleeve
• 10889981159474: TruProfile Plate Caddy
• 10889981143343: Slap Hammer, 3/8 Male
• 10889981289362: Suction Tip, #10
• 10889981289355: Suction Tip, #8
• 10889981286934: Alpha Universal Lid, 20 X 10