IM Nail Dispenser Mold

GUDID 10860003533212

Bonesetter Holdings, LLC

Orthopaedic cement injection cannula

• Primary Device ID: 10860003533212
• NIH Device Record Key: ae26d3fb-c105-4262-b2cd-74716ce9de6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IM Nail Dispenser Mold
• Version Model Number: 01-IMABC13
• Company DUNS: 117402625
• Company Name: Bonesetter Holdings, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter
• Lumen/Inner Diameter: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003533215 [Primary]
GS1	10860003533212 [Package]; Contains: 00860003533215; Package: Box [4 Units]; In Commercial Distribution

FDA Product Code

• OAR: Injector, Vertebroplasty (Does Not Contain Cement)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-06
• Device Publish Date: 2021-09-28

On-Brand Devices [IM Nail Dispenser Mold]

• 10860003533205: 01-IMABC11
• 10860003533212: 01-IMABC13