KMC OneShot Single Balloon Assembly, 8 Gauge, 15mm

GUDID 06938695546586

KMC OneShot Single Balloon Assembly, 8 Gauge, 15mm

Shanghai Kinetic Medical Co., Ltd.

Balloon kyphoplasty kit

• Primary Device ID: 06938695546586
• NIH Device Record Key: 630770d6-cfae-4cb0-aa25-419321c65ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KMC OneShot Single Balloon Assembly, 8 Gauge, 15mm
• Version Model Number: KMCA-201-15
• 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

Customer Support Contacts

• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn
• Phone: +862150720558
• Email: qingmeiwei@shkmc.com.cn

Device Dimensions

• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge
• Balloon Length: 15 Millimeter
• Needle Gauge: 8 Gauge

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938695546586 [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: 2020-10-09
• Device Publish Date: 2020-10-01

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• 06938695546074 - KMC Guide Wire, 1.6mm, Sharp Tip: 2020-10-09 KMC Guide Wire, 1.6mm, Sharp Tip
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