Mistral-Air®

GUDID 18719867002643

Mistral-Air® Lithotomy Plus - SYK

The Surgical Company International B.V.

External circulating-air core temperature regulation system pad, single-use

• Primary Device ID: 18719867002643
• NIH Device Record Key: 26d93c8d-478f-4bb8-8d0d-1421ca884ed2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mistral-Air®
• Version Model Number: MA2455-PM
• Company DUNS: 409656493
• Company Name: The Surgical Company International B.V.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719867002646 [Primary]
GS1	18719867002643 [Package]; Contains: 08719867002646; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171234

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

On-Brand Devices [Mistral-Air®]

• 18719867002667: Mistral-Air® Premium Lithotomy - SYK
• 18719867002643: Mistral-Air® Lithotomy Plus - SYK