ONE TRAY® Sealed Sterilization Container

GUDID 00859522006614

INNOVATIVE STERILIZATION TECHN

Sterilization packaging, reusable

• Primary Device ID: 00859522006614
• NIH Device Record Key: d645f6fc-d7b3-42ca-a8cc-ffdd4b289f05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE TRAY® Sealed Sterilization Container
• Version Model Number: ASSY-2145
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859522006614 [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

[00859522006614]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-08-05

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
• 00859522006058: (L) 23.142" x (H) 8.573" x (W) 11.616"
• 00859522006041: (L) 23.142" x (H) 6.573" x (W) 11.616"
• 00859522006034: (L) 23.142" x (H) 4.573" x (W) 11.616"
• 00859522006027: (L) 20.142" x (H) 8.573" x (W) 11.616"
• 00859522006003: (L) 20.142" x (H) 4.573" x (W) 11.616"