BioProtect Balloon Implant™ System

Basic Information

• Brand Name: BioProtect Balloon Implant™ System
• Primary DI: 07290014878020
• Version / Model: 5135
• Company Name: BIOPROTECT LTD
• Labeler DUNS: 649754660
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-03
• Public Version: 1
• Public Version Date: 2023-11-13
• Public Version Status: New
• Public Device Record Key: af9e376c-e3ac-42eb-b748-1961c832d538

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OVB	Hydrogel Spacer	Radiology	892.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60424	Radiotherapy protection spacer	A sterile, bioabsorbable material (e.g., liquid or gel) intended to be injected between the prostate and the rectum prior to radiotherapy of the prostate, to increase the distance between the prostate and the anterior rectal wall, thereby reducing exposure of the rectum to radiation. It is typically comprised of hyaluronic acid (HA) and may be available in a prefilled syringe. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290014878020	GS1

Premarket Submissions

Submission Number	Supplement Number
K222972	000