PRECICE® Intramedullary Limb Lengthening System Instrument TCD1-000

GUDID 00812258026813

Orthopedic surgical instrument (cannulated driver) - for use with the intramedullary limb lengthening system

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00812258026813
• NIH Device Record Key: 7c59455f-b956-46cb-9ecd-61e89e8451d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE® Intramedullary Limb Lengthening System Instrument
• Version Model Number: TCD1-000
• Catalog Number: TCD1-000
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, 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: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812258026813 [Primary]

FDA Product Code

• HWR: Driver, Prosthesis

Sterilization

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

[00812258026813]

Moist Heat or Steam Sterilization

[00812258026813]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-02-05

On-Brand Devices [PRECICE® Intramedullary Limb Lengthening System Instrument]

• 00812258028787: 3.2mm Short Drill Bit
• 00812258026936: Orthopedic surgical instrument (screw driver) - for use with the intramedullary limb lengthening
• 00812258026929: Orthopedic surgical instrument (screw driver) - for use with the intramedullary limb lengthening
• 00812258026912: Orthopedic surgical instrument (tibial guide) - for use with the intramedullary limb lengthening
• 00812258026905: Orthopedic surgical instrument (tibial guide) - for use with the intramedullary limb lengthening
• 00812258026875: Orthopedic Manual surgical instrument (Screw Driver)
• 00812258026868: Orthopedic surgical instrument (drill guide assembly) - for use with the intramedullary limb len
• 00812258026851: Orthopedic surgical instrument - for use with the intramedullary limb lengthening system
• 00812258026844: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026837: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026820: Orthopedic surgical instrument (intraoperative x-ray ruler) - for use with the intramedullary li
• 00812258026813: Orthopedic surgical instrument (cannulated driver) - for use with the intramedullary limb length
• 00812258026806: Orthopedic surgical instrument (soft tissue protector) - for use with the intramedullary limb le
• 00812258026790: Orthopedic surgical instrument (soft tissue protector) - for use with the intramedullary limb le
• 00812258026783: Orthopedic surgical instrument tray - for use with the intramedullary limb lengthening system
• 00812258026776: Orthopedic surgical instrument tray - for use with the intramedullary limb lengthening system
• 00812258026769: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026752: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026745: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026738: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026721: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026714: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026707: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026691: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026684: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026677: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026660: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026653: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026646: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026639: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026622: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthen
• 00812258026615: Orthopedic surgical instrument (screw gauge) - for use with the intramedullary limb lengthening
• 00812258026608: Orthopedic surgical instrument (AO quick connect) - for use with the intramedullary limb lengthe
• 00812258026592: Orthopedic surgical instrument (guide wire pusher) - for use with the intramedullary limb length
• 00812258026585: Orthopedic surgical instrument (guide wire chuck) - for use with the intramedullary limb lengthe
• 00812258026578: Orthopedic surgical instrument (awl) - for use with the intramedullary limb lengthening system
• 00812258026561: Orthopedic surgical instrument (AO depth gauge) - for use with the intramedullary limb lengtheni
• 00812258026493: Orthopedic surgical instrument (drill guide assembly) - for use with the intramedullary limb len
• 00812258026486: Orthopedic Manual surgical instrument (Non-Ratcheting T-Handle, Ratcheting Quick Connect Handle)
• 00812258026462: Orthopedic surgical instrument (screw driver) - for use with the intramedullary limb lengthening
• 00812258026455: Orthopedic surgical instrument (soft tissue protector) - for use with the intramedullary limb le
• 00812258026448: Orthopedic surgical instrument - for use with the intramedullary limb lengthening system
• 00812258026424: Orthopedic surgical instrument (locking rod) - for use with the intramedullary limb lengthening
• 00812258026417: Orthopedic surgical instrument (tibial guide) - for use with the intramedullary limb lengthening
• 00812258026400: Orthopedic surgical instrument (drill guide) - for use with the intramedullary limb lengthening
• 00812258022341: Orthopedic Manual surgical instrument (Non-Ratcheting T-Handle, Ratcheting Quick Connect Handle)
• 00812258022198: Orthopedic surgical instrument (screw driver) - for use with the intramedullary limb lengthening
• 00812258022181: Orthopedic surgical instrument (screw driver) - for use with the intramedullary limb lengthening
• 00812258022174: Orthopedic Manual surgical instrument (Non-Ratcheting T-Handle, Ratcheting Quick Connect Handle)
• 00812258022167: Orthopedic surgical instrument - for use with the intramedullary limb lengthening system