111653

GUDID 00848486017316

CHECKPOINT 3.5MM HEX, IMPACTION

MAKO SURGICAL CORP.

Imaging lesion localization marker, implantable

• Primary Device ID: 00848486017316
• NIH Device Record Key: 07a6c184-bc47-4634-8089-ea9446f099ac
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 111653
• Catalog Number: 111653
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486017316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112507
• Premarket Notification: K121064

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

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: 2018-07-06
• Device Publish Date: 2016-09-24

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