SteriStay

GUDID 07350101640043

SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flow of air over sterile instruments and goods. The airflow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms.

Toul Meditech AB

Surgical laminar airflow unit

• Primary Device ID: 07350101640043
• NIH Device Record Key: a20980a0-9146-4f87-a06e-e582060ba293
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriStay
• Version Model Number: B2
• Company DUNS: 427895198
• Company Name: Toul Meditech AB
• Device Count: 1
• 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: 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
GS1	07350101640043 [Primary]

FDA Product Code

• ORC: Air Filter Portable Apparatus

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: 2019-09-13
• Device Publish Date: 2019-09-05

Devices Manufactured by Toul Meditech AB

• 07350101640050 - Sterile Shield: 2021-06-08 The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ultra clean air devices from Toul Medite
• 07350101640098 - SurgiCube drape: 2020-12-18 Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the out
• 07350101640043 - SteriStay: 2019-09-13SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flow of air over sterile instruments and goods. The airflow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms.
• 07350101640043 - SteriStay: 2019-09-13 SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flo
• 07350101640005 - Operio: 2019-04-16 Operio Mobile is a clean air zone unit, with an integrated detachable instrument tray, to be used in the operating zone, which p
• 07350101640029 - Sterile Shield: 2019-03-11 The Sterile shield LAF 02 is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech