Restore IQ System

GUDID 00860190001450

Platform, Large - Purple

RESTORE MEDICAL SOLUTIONS, INC.

Sterilization/disinfection container

• Primary Device ID: 00860190001450
• NIH Device Record Key: beca7c70-74f0-49df-bbe4-9b28f271ac75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore IQ System
• Version Model Number: R-A1020-FR2-40
• Company DUNS: 032044173
• Company Name: RESTORE MEDICAL SOLUTIONS, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860190001450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131455

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

[00860190001450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2018-02-23

On-Brand Devices [Restore IQ System]

• 00860190001481: Platform, Large - Blue
• 00860190001474: Platform, Medium - Blue
• 00860190001467: Platform, Small - Blue
• 00860190001450: Platform, Large - Purple
• 00860190001443: Platform, Medium - Purple
• 00860190001436: Platform, Small - Purple