StabiliT Complete Fracture Kit 3512-01

GUDID 00850696006387

Dfine, Inc.

Orthopaedic cement, non-medicated

• Primary Device ID: 00850696006387
• NIH Device Record Key: ef972480-8219-4990-a8fc-58b54e04231d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StabiliT Complete Fracture Kit
• Version Model Number: 3512-01
• Catalog Number: 3512-01
• 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: true
• 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	00850696006387 [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: 2016-03-23

On-Brand Devices [StabiliT Complete Fracture Kit ]

• 00850696006554: 3512
• 00850696006547: 3506
• 00850696006387: 3512-01
• 00850696006370: 3506-01