Home GUDID 00864661000102 SpaceOAR System
Primary DI 00864661000102
Brand SpaceOAR System
Company BOSTON SCIENTIFIC CORPORATION
Model SO-2101
Catalog number SO-2101
Device description The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use.
Published 2015-12-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00864661000102 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00864661000102 00864661000102 864661000102 0864661000102
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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 021717889 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290014878020 BioProtect Balloon Implant™ System BIOPROTECT LTD OVB 2023-11-03 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