Tool Kit

GUDID 06938695520012

KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump

Shanghai Kinetic Medical Co., Ltd.

Bone access channel kit

• Primary Device ID: 06938695520012
• NIH Device Record Key: c0e18e91-d508-478d-8188-9c148b9eed52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tool Kit
• Version Model Number: FG2001
• Company DUNS: 528198569
• Company Name: Shanghai Kinetic Medical Co., Ltd.
• 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: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938695520012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113742

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

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: 2020-01-14
• Device Publish Date: 2020-01-06

On-Brand Devices [Tool Kit]

• 06938695520029: KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM
• 06938695520012: KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM