Home GUDID 07290014878020 BioProtect Balloon Implant™ System
Primary DI 07290014878020
Brand BioProtect Balloon Implant™ System
Company BIOPROTECT LTD
Model 5135
Published 2023-11-03
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OVB Hydrogel Spacer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVB Hydrogel Spacer Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290014878020 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290014878020 07290014878020 7290014878020
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 649754660 Device count 1 Serial number true Manufacturing date on label true Expiration date on label true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850004725139 Barrigel PALETTE LIFE SCIENCES, INC. OVB 2023-03-01 00850004725108 Barrigel PALETTE LIFE SCIENCES, INC. OVB 2022-11-30 00850004725115 Barrigel Applicator Needle PALETTE LIFE SCIENCES, INC. OVB 2022-11-30 00864661000140 SpaceOAR VUE™ System - 10mL BOSTON SCIENTIFIC CORPORATION OVB 2019-10-01 00864661000102 SpaceOAR System BOSTON SCIENTIFIC CORPORATION OVB 2015-12-10