SpaceOAR VUE™ System - 10mL

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: SpaceOAR VUE™ System - 10mL FDA UDI
Generic Name: Radiotherapy protection spacer FDA UDI
Device Name: SpaceOAR Systems FDA UDI
Model / Reference: SV-2101 FDA UDI
Description: SpaceOAR Systems FDA UDI

Identifiers

Catalog Number: SV-2101 FDA UDI
Primary DI / UDI-DI: 00864661000140 FDA UDI
FDA Product Code: OVB FDA UDI
GMDN Term: Radiotherapy protection spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Total Volume — 10 Milliliter FDA UDI

Category: Radiotherapy protection spacer

SpaceOAR VUE™ System - 10mL by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiotherapy protection spacer.

Barrigel — PALETTE LIFE SCIENCES · Class II
BioProtect Balloon Implant™ System — BIOPROTECT LTD · Class II
Barrigel — PALETTE LIFE SCIENCES · Class II
SpaceOAR System — Boston Scientific · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Boston Scientific

Sources (1)

FDA UDI 9bc09613-cf12-4c67-a289-f7072dc8fbb2 35 fields · synced May 30, 2026