CarboJet XF® Bone Preparation System 27-100-1010

GUDID 00818720012421

Handpiece Set with 40° Nozzle and Splash Shield

Kinamed, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00818720012421
• NIH Device Record Key: 0ddd58ee-8944-4a46-b499-922b1803ba1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboJet XF® Bone Preparation System
• Version Model Number: 27-100-1010
• Catalog Number: 27-100-1010
• Company DUNS: 184896645
• Company Name: Kinamed, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818720012421 [Primary]
GS1	00818720013190 [Package]; Package: Pack [6 Units]; In Commercial Distribution
GS1	00818720013206 [Package]; Package: Pack [10 Units]; In Commercial Distribution

FDA Product Code

• FQH: Lavage, Jet

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: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [CarboJet XF® Bone Preparation System]

• 00818720013145: Handpiece Set with Femoral Canal Nozzle
• 00818720012438: Splash Shield
• 00818720012421: Handpiece Set with 40° Nozzle and Splash Shield
• 00818720012414: Handpiece Set with 40° Nozzle