StabiliT First Fracture Kit 3353-01

GUDID 00850696006233

Dfine, Inc.

Orthopaedic cement, non-medicated

• Primary Device ID: 00850696006233
• NIH Device Record Key: 2cc393e1-f09b-4bd8-9df7-0262d6e3d759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StabiliT First Fracture Kit
• Version Model Number: 3353-01
• Catalog Number: 3353-01
• 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	00850696006233 [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: 2016-01-27

On-Brand Devices [StabiliT First Fracture Kit ]

• 00850696006530: 3353
• 00850696006523: 2003
• 00850696006233: 3353-01
• 00850696006226: 2003-1