HEAD SUPPORT 1358227 BIOFLEK RISER
Bio-Flek - 1358227
Device Description
A device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. It is available in various shapes and sizes and might include mechanisms to enable adjustments in relation to the table top. It does not include components intended for immobilization of the head (i.e., not a positioner). This is a reusable device after appropriate cleaning.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: EPW
Device Name: Support, Head, Surgical, Ent
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: SU
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: 878.4950
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 00681490039024
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