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 Surgical laminar airflow unit Surgical laminar airflow unit Surgical laminar airflow unit Surgical laminar airflow unit Surgical laminar airflow unit Surgical laminar airflow unit Surgical laminar airflow unit Surgical laminar airflow unit Surgical laminar airflow unit 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