Naviagtion Instrumentation 01-1800-3001

GUDID 00840194427951

4.0mm Nav Guide Window Tap

ORTHOPEDIATRICS CORP.

Bone tap, reusable

• Primary Device ID: 00840194427951
• NIH Device Record Key: c1c511d6-fee1-4076-b197-11f6f0eb3625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Naviagtion Instrumentation
• Version Model Number: 01-1800-3001
• Catalog Number: 01-1800-3001
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194427951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203573

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

[00840194427951]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-03-20
• Device Publish Date: 2022-12-15

On-Brand Devices [Naviagtion Instrumentation]

• 00840194427951: 4.0mm Nav Guide Window Tap
• 00840194427999: 5.5mm Nav Guide Window Tap
• 00840194427982: 4.5mm Nav Guide Window Tap
• 00840194427975: 6.0mm Nav Guide Window Tap
• 00840194427968: 5.0mm Nav Guide Window Tap