Restore Intelligent Sterilization Tray

GUDID 00860190001405

modular tray, large size - 10 x 20 inch

RESTORE MEDICAL SOLUTIONS, INC.

Sterilization/disinfection container

• Primary Device ID: 00860190001405
• NIH Device Record Key: 38c01f16-9897-4366-a6d6-8f4e2915ceaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore Intelligent Sterilization Tray
• Version Model Number: R-10204-00
• 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	00860190001405 [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

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

Moist Heat or Steam Sterilization

[00860190001405]

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

Devices Manufactured by RESTORE MEDICAL SOLUTIONS, INC.

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• 00860190001443 - Restore IQ System: 2019-09-10 Platform, Medium - Purple
• 00860190001450 - Restore IQ System: 2019-09-10 Platform, Large - Purple
• 00860190001467 - Restore IQ System: 2019-09-10 Platform, Small - Blue
• 00860190001474 - Restore IQ System: 2019-09-10 Platform, Medium - Blue