PRECICE® System PFD1-000

GUDID 00887517940704

PRECICE Fast Distractor

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Distraction plate/rod preimplantation adjustment device

• Primary Device ID: 00887517940704
• NIH Device Record Key: f58fc53b-745f-4be8-b01f-857810b4cd16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE® System
• Version Model Number: PFD1-000
• Catalog Number: PFD1-000
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517940704 [Primary]

FDA Product Code

• HWN: Instrument, Compression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-06-11

On-Brand Devices [PRECICE® System ]

• 00887517940704: PRECICE Fast Distractor
• 00887517985200: PRECICE Drill Bit, 155mm 3.5 Step Short
• 00887517016010: PRECICE Olive Wire, 2.0x150mm
• 00887517006547: PRECICE Drill Bit, 3.5mm Calibrated AO
• 00887517937872: TARGETING HANDLE, PRECICE
• 00887517937858: LOCKING BOLT, SUPRAPATELLAR
• 00887517937841: LOCKING BOLT
• 00887517937834: TARGETING HANDLE, SUPRAPATELLAR
• 00887517937810: Locking Screw, 4.5x100mm Fully Threaded
• 00887517937803: Locking Screw, 4.5x95mm Fully Threaded
• 00887517937797: Locking Screw, 4.5x90mm Fully Threaded
• 00887517937780: Locking Screw, 4.5x85mm Fully Threaded
• 00887517937773: Locking Screw, 4.5x80mm Fully Threaded
• 00887517937766: Locking Screw, 4.5x47.5mm Fully Threaded
• 00887517937759: Locking Screw, 4.5x42.5mm Fully Threaded
• 00887517937742: Locking Screw, 4.5x37.5mm Fully Threaded
• 00887517937735: Locking Screw, 4.5x32.5mm Fully Threaded
• 00887517937728: Locking Screw, 4.5x27.5mm Fully Threaded
• 00887517937711: Locking Screw, 4.5x22.5mm Fully Threaded
• 00887517937285: Antegrade Tibia 10° Bend, 10.7x150mm
• 00887517937278: Retrograde Femur 10° Bend, 10.7x160 mm
• 00887517937261: Ante Femur Troch 10 ° Bend, 10.7x160mm
• 00887517937254: Retrograde Femur Str, 12.5x195mm