Operio

GUDID 07350101640005

Operio Mobile is a clean air zone unit, with an integrated detachable instrument tray, to be used in the operating zone, which produces a directed, non-turbulent ultraclean air flow to the surgical site during ophthalmic, orthopedic and neuro surgery and to the sterile instruments used during surgery.

Toul Meditech AB

Surgical laminar airflow unit

• Primary Device ID: 07350101640005
• NIH Device Record Key: 074ac082-2f53-47ed-9f1d-23a928007f7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Operio
• Version Model Number: Mobile
• 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	07350101640005 [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: 2019-04-16
• Device Publish Date: 2019-04-08

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: 2019-09-13 SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flo
• 07350101640005 - Operio: 2019-04-16Operio Mobile is a clean air zone unit, with an integrated detachable instrument tray, to be used in the operating zone, which produces a directed, non-turbulent ultraclean air flow to the surgical site during ophthalmic, orthopedic and neuro surgery and to the sterile instruments used during surgery.
• 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