FDA.reportPublic FDA data

SpaceOAR VUE™ System - 10mL

Primary DI
00864661000140
Brand
SpaceOAR VUE™ System - 10mL
Company
BOSTON SCIENTIFIC CORPORATION
Model
SV-2101
Catalog number
SV-2101
Device description
SpaceOAR Systems
Published
2019-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVBHydrogel spacer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVBHydrogel SpacerRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864661000140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864661000140008646610001408646610001400864661000140

GMDN Terms#

Term, Definition table
TermDefinition
Radiotherapy protection spacerA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Sterilization Methods#

Method table
Method

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290014878020BioProtect Balloon Implant™ SystemBIOPROTECT LTDOVB2023-11-03
00850004725139BarrigelPALETTE LIFE SCIENCES, INC.OVB2023-03-01
00850004725108BarrigelPALETTE LIFE SCIENCES, INC.OVB2022-11-30
00850004725115Barrigel Applicator NeedlePALETTE LIFE SCIENCES, INC.OVB2022-11-30
00864661000102SpaceOAR SystemBOSTON SCIENTIFIC CORPORATIONOVB2015-12-10