BioProtect Balloon Implant™ System

GUDID 07290014878020

BIOPROTECT LTD

Radiotherapy protection spacer

• Primary Device ID: 07290014878020
• NIH Device Record Key: af9e376c-e3ac-42eb-b748-1961c832d538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioProtect Balloon Implant™ System
• Version Model Number: 5135
• Company DUNS: 649754660
• Company Name: BIOPROTECT LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014878020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222972

FDA Product Code

• OVB: Hydrogel Spacer

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: 2023-11-13
• Device Publish Date: 2023-11-03