RESTORIS, PST, RIO 209360

GUDID 00848486022983

Offset Shell Impactor

MAKO SURGICAL CORP.

Orthopaedic implant impactor

• Primary Device ID: 00848486022983
• NIH Device Record Key: 51caeee7-fd2a-48d3-9610-a3eb39aff6af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORIS, PST, RIO
• Version Model Number: 209360
• Catalog Number: 209360
• 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	00848486022983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121064

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00848486022983]

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

On-Brand Devices [RESTORIS, PST, RIO]

• 00848486030049: Shell Impactor, Offset
• 00848486023010: INLINE-OFFSET SHELL IMPACTOR
• 00848486022983: Offset Shell Impactor
• 00848486022907: SHELL IMPACTOR, STRAIGHT