SurgiCube drape

GUDID 07350101640098

Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles.

Toul Meditech AB

Surgical dressing/drape kit

• Primary Device ID: 07350101640098
• NIH Device Record Key: 2270f729-40f8-479a-9ece-871c74a0181a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiCube drape
• Version Model Number: SCDR180
• 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: 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	07350101640081 [Package]; Package: Cartong box [42 Units]; In Commercial Distribution
GS1	07350101640098 [Primary]

FDA Product Code

• HMT: Drape, Patient, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-18
• Device Publish Date: 2020-12-10

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: 2020-12-18Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles.
• 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: 2019-04-16 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