BioProtect Balloon Implant™ System

GUDID 07290014878020

BIOPROTECT LTD

Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer 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