700000357480

GUDID 07613327468311

Crest Drill Guide

MAKO SURGICAL CORP.

Surgical drill guide, reusable

• Primary Device ID: 07613327468311
• NIH Device Record Key: c5af44a0-7b74-4459-b63c-6eb775a4288e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 700000357480
• Catalog Number: 700000357480
• Company DUNS: 175239677
• Company Name: MAKO SURGICAL 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(954)628-0802
• Email: MakoCustomerService@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327468311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193128

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

[07613327468311]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2020-02-28

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• 07613327600001 - Mako: 2023-07-31
• 07613327600063 - Mako: 2023-07-31
• 07613327600070 - Mako: 2023-07-31
• 07613327601008 - Mako: 2023-07-31