ONE TRAY® Sealed Sterilization Container

GUDID 00859522006102

INNOVATIVE STERILIZATION TECHN

Sterilization packaging, reusable

• Primary Device ID: 00859522006102
• NIH Device Record Key: 5d88c08f-d2ce-4dfd-9df0-eab19d7b9b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE TRAY® Sealed Sterilization Container
• Version Model Number: M2104
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859522006102 [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

[00859522006102]

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: 2016-09-24

On-Brand Devices [ONE TRAY® Sealed Sterilization Container]

• 00859522006638: ASSY-2445
• 00859522006621: ASSY-2425
• 00859522006614: ASSY-2145
• 00859522006607: ASSY-2125
• 00859522006539: ASSY-2435
• 00859522006522: ASSY-2415
• 00859522006515: ASSY-2135
• 00859522006508: ASSY-2115
• 00859522006409: CASE-1000-13
• 00859522006157: M2408
• 00859522006140: M2406
• 00859522006133: M2404
• 00859522006126: M2108
• 00859522006119: M2106
• 00859522006102: M2104