206693

GUDID 00848486032135

MICS Adapter Cap

MAKO SURGICAL CORP.

Electrosurgical handpiece/electrode holder, reusable

• Primary Device ID: 00848486032135
• NIH Device Record Key: 16696b4b-6f16-4d6e-a01e-901047c60475
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 206693
• Catalog Number: 206693
• 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	00848486032135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141989

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00848486032135]

Moist Heat or Steam Sterilization

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

Devices Manufactured by MAKO SURGICAL CORP.

• 07613327625868 - INSTRUMENT: 2024-10-14 Spine Pedicle End Effector
• 07613327625875 - INSTRUMENT: 2024-10-14 Spine Pedicle Registration Tool
• 07613327624304 - NA: 2024-09-26 Robotic Arm
• 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