- Physicians Office Resource

KIT OCN003 OSTEOCOOL BONE ACCESS 8G 090
OsteoCool Bone Access Kits - OCN003

Device Description

A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Store in a cool, dry place

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LXH

Device Name: Orthopedic Manual Surgical Instrument

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 888.4540

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 00763000027056

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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