n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551203835
• Version / Model: 810503
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-04
• Public Version: 1
• Public Version Date: 2018-10-05
• Public Version Status: New
• Public Device Record Key: d7b26194-f818-44f6-a2f8-f9b20a02b3b7

Device Description

Needle, Tonsil, 90° forward angle

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32975	Tonsil suction cannula	A long metal tube that is attached to a suction system and manipulated by the surgeon for the evacuation (suctioning) of blood, fluids, and other tissue debris from the surgical site during a tonsillectomy or other oral and laryngeal surgical procedures. This is a dedicated device that typically attaches to a dedicated handpiece and a suction system. Its distal end will typically be curved to facilitate its application within the oral cavity and throat and may include multiple apertures to negate the problem of the suction being to aggressive (i.e., the tip grabbing at the tissue). This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551203835	GS1