Precice Opty-Line System

GUDID 00887517940339

PRECICE Opty-Line Reamers-Nail Entry Set

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Instrument tray, reusable
Primary Device ID00887517940339
NIH Device Record Key8e16eee8-559d-4801-b07e-e6e1348a6067
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecice Opty-Line System
Version Model NumberITO1-000
Company DUNS837845234
Company NameNUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517940339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-10
Device Publish Date2022-03-02

Devices Manufactured by NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

00195377168276 - PRECICE Screws2024-01-19 5.0 mm X 100 mm Locking Screw, Fully Threaded
00195377168283 - PRECICE Screws2024-01-19 5.0 mm X 95 mm Locking Screw, Fully Threaded
00195377168290 - PRECICE Screws2024-01-19 5.0 mm X 80 mm Locking Screw, Fully Threaded
00195377168603 - PRECICE Screws2024-01-19 5.0 mm X 70 mm Locking Screw, Fully Threaded
00195377168610 - PRECICE Screws2024-01-19 5.0 mm X 60 mm Locking Screw, Fully Threaded
00195377168627 - PRECICE Screws2024-01-19 5.0 mm X 50 mm Locking Screw, Fully Threaded
00195377168634 - PRECICE Screws2024-01-19 5.0 mm X 45 mm Locking Screw, Fully Threaded
00195377168641 - PRECICE Screws2024-01-19 5.0 mm X 32.5 mm Locking Screw, Fully Threaded

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