SpaceOAR VUE™ System - 10mL SV-2101

GUDID 00864661000140

SpaceOAR Systems

AUGMENIX, INC.

Radiotherapy protection spacer

• Primary Device ID: 00864661000140
• NIH Device Record Key: 9bc09613-cf12-4c67-a289-f7072dc8fbb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpaceOAR VUE™ System - 10mL
• Version Model Number: SV-2101
• Catalog Number: SV-2101
• Company DUNS: 960905862
• Company Name: AUGMENIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 10 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864661000140 [Primary]

FDA Product Code

• OVB: Hydrogel spacer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-09
• Device Publish Date: 2019-10-01

Devices Manufactured by AUGMENIX, INC.

• 00864661000140 - SpaceOAR VUE™ System - 10mL: 2019-10-09SpaceOAR Systems
• 00864661000140 - SpaceOAR VUE™ System - 10mL: 2019-10-09 SpaceOAR Systems
• 10864661000116 - TraceIT Tissue Marker 5-UP: 2019-09-30 TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, rad
• 10864661000130 - TraceIT Tissue Marker 3mL 5-UP: 2019-09-30 TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, rad
• 00864661000102 - SpaceOAR System: 2019-09-30 The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system pack
• 00864661000119 - TraceIT Tissue Marker 1-UP: 2019-09-30 TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, rad
• 00864661000133 - TraceIT Tissue Marker 3mL 1-UP: 2019-09-30 TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, rad