AccessGUDID - DEVICE: SpaceOAR System (00864661000102)

GUDID

Device Identifier (DI) Information

Brand Name: SpaceOAR System
Version or Model: SO-2101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SO-2101
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00864661000102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use.

Device Characteristics

What MRI safety information does the labeling contain?	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):	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
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb15cd6b-8cc5-4d39-85e6-e83a13ff8bde
Public Version Date: September 19, 2024
Public Version Number: 6
DI Record Publish Date: December 10, 2015