KMC Double Balloon Assembly, 8 Gauge, 10mm

Basic Information

• Brand Name: KMC Double Balloon Assembly, 8 Gauge, 10mm
• Primary DI: 06938695546487
• Version / Model: KMCA-100-10
• Company Name: Shanghai Kinetic Medical Co., Ltd.
• Labeler DUNS: 528198569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-01
• Public Version: 1
• Public Version Date: 2020-10-09
• Public Version Status: New
• Public Device Record Key: f26e2993-99d8-4b82-8977-767c4d6530da

Device Description

KMC Double Balloon Assembly, 8 Gauge, 10mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDN	Cement, Bone, Vertebroplasty	Orthopedic	888.3027	2
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47129	Balloon kyphoplasty kit	A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06938695546487	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113742	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	8	Gauge
Balloon Length	10	Millimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius