StabiliT ER2 Bone Cement 1135

GUDID 00850696006417

Dfine, Inc.

Orthopaedic cement, non-medicated

• Primary Device ID: 00850696006417
• NIH Device Record Key: b189a92a-c734-4a37-af56-a561f92f7e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StabiliT ER2 Bone Cement
• Version Model Number: 1135
• Catalog Number: 1135
• Company DUNS: 169957607
• Company Name: Dfine, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850696006417 [Primary]

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-19
• Device Publish Date: 2015-12-17

Devices Manufactured by Dfine, Inc.

• 00850696006004 - SpineSTAR Ablation Instrument (10|15, Long): 2020-03-19
• 00850696006011 - SpineSTAR Ablation Instrument (5|10, Long): 2020-03-19
• 00850696006028 - StabiliT Bone Cement and Saturate Mixing System: 2020-03-19
• 00850696006073 - StabiliT VP Fracture Kit: 2020-03-19
• 00850696006226 - StabiliT First Fracture Kit: 2020-03-19
• 00850696006233 - StabiliT First Fracture Kit: 2020-03-19
• 00850696006240 - STAR Tumor Ablation Kit (10|15, Short) with PowerCURVE: 2020-03-19 ala carte packaging
• 00850696006257 - STAR Tumor Ablation Kit (5|10, Long) with PowerCURVE: 2020-03-19 ala carte packaging