Calibration End Effector Inverted 208922

GUDID 00848486022747

Calibration End Effector Inverted

MAKO SURGICAL CORP.

Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor 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

Devices Manufactured by MAKO SURGICAL CORP.

• 07613327599985 - Mako: 2023-07-31
• 07613327600001 - Mako: 2023-07-31
• 07613327600063 - Mako: 2023-07-31
• 07613327600070 - Mako: 2023-07-31
• 07613327601008 - Mako: 2023-07-31
• 00848486022747 - Calibration End Effector Inverted: 2022-10-13Calibration End Effector Inverted
• 00848486022747 - Calibration End Effector Inverted: 2022-10-13 Calibration End Effector Inverted
• 07613327395341 - Mako: 2021-04-07
• 07613327395280 - NA: 2020-12-23