Sterilization Tray

GUDID M896IBIT00010

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Sterilization/disinfection container, reusable

• Primary Device ID: M896IBIT00010
• NIH Device Record Key: 519a2082-202f-4b10-85e1-8b09edb2fadf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilization Tray
• Version Model Number: IB-IT-0001
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, 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: false
• Serial Number: true
• 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
HIBCC	M896IBIT00010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171520

FDA Product Code

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

Sterilization

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

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

[M896IBIT00010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-06
• Device Publish Date: 2022-11-28

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