Calibration End Effector Inverted 208922

GUDID 00848486022747

Calibration End Effector Inverted

MAKO SURGICAL CORP.

Patient positioning sensor

• Primary Device ID: 00848486022747
• NIH Device Record Key: dc7b9cc4-41d0-40ae-92bd-808f52fe27a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibration End Effector Inverted
• Version Model Number: 208922
• Catalog Number: 208922
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486022747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220459

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

[00848486022747]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-13
• Device Publish Date: 2022-10-05

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• 07613327624304 - NA: 2024-09-26 Robotic Arm