Sterile Shield

GUDID 07350101640050

The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech AB, to function as a sterile protection for preventing airborne contamination in the surgical environment. In addition, the sterile shield LAF 02-D has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02-D is attached on the Operio device on the outlet of the HEPA filtered ultra clean air. Instructions on how to use and mount the sterile shield LAF 02-D is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction.

Toul Meditech AB

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• Primary Device ID: 07350101640050
• NIH Device Record Key: a44b1f2f-e318-4217-94d3-156f62ecc8af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Shield
• Version Model Number: LAF-02-D
• Company DUNS: 427895198
• Company Name: Toul Meditech AB
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	07350101640050 [Package]; Contains: 07350101640067; Package: Cardbordbox [2 Units]; In Commercial Distribution
GS1	07350101640067 [Primary]
GS1	07350101640074 [Unit of Use]

FDA Product Code

• ORC: Air Filter Portable Apparatus

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-08
• Device Publish Date: 2019-12-20

On-Brand Devices [Sterile Shield]

• 07350101640029: The Sterile shield LAF 02 is a single-use sterile consumable to be used together with ultra clea
• 07350101640050: The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ultra cl