RESTORIS, PST, Mako 212260

GUDID 00848486030964

Offset Shell Impactor

MAKO SURGICAL CORP.

Orthopaedic implant impactor

• Primary Device ID: 00848486030964
• NIH Device Record Key: 1e83abef-1b09-43d7-93e6-24d0e0639a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORIS, PST, Mako
• Version Model Number: 212260
• Catalog Number: 212260
• 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	00848486030964 [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

[00848486030964]

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

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