Osteomedix, Inc.

GUDID 00863602000300

OSTEOMEDIX, INC.

Orthopaedic bone particle collector, single-use

• Primary Device ID: 00863602000300
• NIH Device Record Key: 486b4490-a8d5-4c8a-aa76-5d63386c988a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteomedix, Inc.
• Version Model Number: BDC-Cervical
• Company DUNS: 080424972
• Company Name: OSTEOMEDIX, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863602000300 [Primary]

FDA Product Code

• GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-27