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SpaceOAR System

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
SpaceOAR System FDA UDI
Generic Name
Radiotherapy protection spacer FDA UDI
Device Name
The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use. FDA UDI
Model / Reference
SO-2101 FDA UDI
Description
The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use. FDA UDI

Identifiers

Catalog Number
SO-2101 FDA UDI
Primary DI / UDI-DI
00864661000102 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiotherapy protection spacer

SpaceOAR System by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiotherapy protection spacer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI fb15cd6b-8cc5-4d39-85e6-e83a13ff8bde 35 fields · synced Jun 8, 2026