StabiliT MX Fracture Kit MX-2100S-01

GUDID 00850696006622

Dfine, Inc.

Orthopaedic cement, non-medicated

• Primary Device ID: 00850696006622
• NIH Device Record Key: 214fa57b-244d-4665-81dc-5205211c95d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StabiliT MX Fracture Kit
• Version Model Number: MX-2100S-01
• Catalog Number: MX-2100S-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	00850696006622 [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: 2016-07-06

On-Brand Devices [StabiliT MX Fracture Kit ]

• 00850696006639: MX-2100L-01
• 00850696006622: MX-2100S-01
• 00850696006615: MX-1100L-01
• 00850696006608: Blister tray packaging
• 00850696006493: MX-2100L
• 00850696006486: MX-2100S
• 00850696006479: MX-1100L
• 00850696006462: MX-1100S
• 00850696006318: MX-1100S-01
• 00850696006301: MX-1100L-01
• 00850696006295: MX-2100S-01
• 00850696006288: MX-2100L-01