BONE FILLER DEVICE F25R 3 VALUE BFD

BONE FILLER DEVICE F25R 3 VALUE BFD
Kyphon ELEMENT Bone Filler Device - F25R

Device Description

A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. 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: KIH

Device Name: Dispenser, Cement

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: 888.4200

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 00763000026714

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