AccessGUDID - DEVICE: SpaceOAR VUE™ System

GUDID

Device Identifier (DI) Information

Brand Name: SpaceOAR VUE™ System - 10mL
Version or Model: SV-2101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SV-2101
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00864661000140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: SpaceOAR Systems

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60424	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OVB	Hydrogel spacer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: 9bc09613-cf12-4c67-a289-f7072dc8fbb2
Public Version Date: November 17, 2020
Public Version Number: 2
DI Record Publish Date: October 01, 2019