SpaceOAR System SO-2101

GUDID 00864661000102

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

AUGMENIX, INC.

Radiotherapy protection spacer

• Primary Device ID: 00864661000102
• NIH Device Record Key: fb15cd6b-8cc5-4d39-85e6-e83a13ff8bde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpaceOAR System
• Version Model Number: SO-2101
• Catalog Number: SO-2101
• Company DUNS: 960905862
• Company Name: AUGMENIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864661000102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140030

FDA Product Code

• OVB: Hydrogel Spacer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-30
• Device Publish Date: 2015-12-10

Devices Manufactured by AUGMENIX, INC.

• 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: 2019-09-30The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use.
• 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