Duns Number:960905862
Device Description: The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydr The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use.
Catalog Number
SO-2101
Brand Name
SpaceOAR System
Version/Model Number
SO-2101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OVB
Product Code Name
Hydrogel Spacer
Public Device Record Key
fb15cd6b-8cc5-4d39-85e6-e83a13ff8bde
Public Version Date
September 30, 2019
Public Version Number
5
DI Record Publish Date
December 10, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |