Precice Opty-Line System

GUDID 00887517940339

PRECICE Opty-Line Reamers-Nail Entry Set

NUVASIVE SPECIALIZED ORTHOPEDICS, 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 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: 00887517940339
• NIH Device Record Key: 8e16eee8-559d-4801-b07e-e6e1348a6067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precice Opty-Line System
• Version Model Number: ITO1-000
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517940339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151594

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

[00887517940339]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-10
• Device Publish Date: 2022-03-02

Devices Manufactured by NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

• 00195377168276 - PRECICE Screws: 2024-01-19 5.0 mm X 100 mm Locking Screw, Fully Threaded
• 00195377168283 - PRECICE Screws: 2024-01-19 5.0 mm X 95 mm Locking Screw, Fully Threaded
• 00195377168290 - PRECICE Screws: 2024-01-19 5.0 mm X 80 mm Locking Screw, Fully Threaded
• 00195377168603 - PRECICE Screws: 2024-01-19 5.0 mm X 70 mm Locking Screw, Fully Threaded
• 00195377168610 - PRECICE Screws: 2024-01-19 5.0 mm X 60 mm Locking Screw, Fully Threaded
• 00195377168627 - PRECICE Screws: 2024-01-19 5.0 mm X 50 mm Locking Screw, Fully Threaded
• 00195377168634 - PRECICE Screws: 2024-01-19 5.0 mm X 45 mm Locking Screw, Fully Threaded
• 00195377168641 - PRECICE Screws: 2024-01-19 5.0 mm X 32.5 mm Locking Screw, Fully Threaded