ViVi Helmet HPL 80130

GUDID 09009607801301

THI Total Healthcare Innovation GmbH

Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system Surgical helmet system

• Primary Device ID: 09009607801301
• NIH Device Record Key: 73e25561-7a20-4180-9fa7-160da0c2abbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViVi Helmet HPL
• Version Model Number: 80130
• Catalog Number: 80130
• Company DUNS: 300188850
• Company Name: THI Total Healthcare Innovation GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09009607801301 [Primary]

FDA Product Code

• FXY: Hood, Surgical

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: 2023-11-20
• Device Publish Date: 2023-11-10

Devices Manufactured by THI Total Healthcare Innovation GmbH

• 09009607801004 - ViVi Helmet: 2023-11-20
• 09009607801301 - ViVi Helmet HPL: 2023-11-20
• 09009607801301 - ViVi Helmet HPL: 2023-11-20
• 09009607812000 - ViVi Hood: 2023-11-20