V. Mueller LEWY
V. Mueller - BE598
Device Description
A rigid, sharp, bevel-edged, hollow, tubular metal instrument intended to be used for injection of a vocal cord medialization implant, in gel form, into the vocal cord without direct visualization. It is typically curved to enable navigation of the pharynx; it is not intended to be used with an endoscope. This is a reusable device intended to be sterilized prior to use.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: FMI
Device Name: Needle, Hypodermic, Single Lumen
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
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: 880.5570
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 10885403014789
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