ONE TRAY® Processing Kit

GUDID 00859522006010

INNOVATIVE STERILIZATION TECHN

Sterilization packaging, reusable

• Primary Device ID: 00859522006010
• NIH Device Record Key: de3bef53-b4f9-4eba-a52a-f1f1298a612b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE TRAY® Processing Kit
• Version Model Number: OTK-BOX50
• Company DUNS: 078885794
• Company Name: INNOVATIVE STERILIZATION TECHN
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00859522006010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052567

FDA Product Code

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

Sterilization

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

[00859522006010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-08-03

Devices Manufactured by INNOVATIVE STERILIZATION TECHN

• 00859522006010 - ONE TRAY® Processing Kit: 2019-11-08
• 00859522006010 - ONE TRAY® Processing Kit: 2019-11-08
• 00859522006102 - ONE TRAY® Sealed Sterilization Container: 2019-11-08
• 00859522006119 - ONE TRAY® Sealed Sterilization Container: 2019-11-08
• 00859522006126 - ONE TRAY® Sealed Sterilization Container: 2019-11-08
• 00859522006133 - ONE TRAY® Sealed Sterilization Container: 2019-11-08
• 00859522006140 - ONE TRAY® Sealed Sterilization Container: 2019-11-08
• 00859522006157 - ONE TRAY® Sealed Sterilization Container: 2019-11-08
• 00859522006409 - ONE TRAY® Sealed Sterilization Container: 2019-11-08