Spetzler Lighted Suction Tube, 3 French, 160mm, Storz Connector

Basic Information

• Brand Name: Spetzler Lighted Suction Tube, 3 French, 160mm, Storz Connector
• Primary DI: 10856312006035
• Version / Model: DN1403-160
• Company Name: KATALYST SURGICAL LLC
• Labeler DUNS: 007883297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-07-18
• Public Version: 5
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: ba235bb5-ac50-4896-b2bb-0fe696c484b3

Device Description

Spetzler Lighted Suction Tube, 3 French, 160mm, Storz Connector

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	878.4580	2
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38518	Surgical/emergency suction cannula, illuminating, single-use	An atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10856312006035	GS1
Unit of Use	00856312006038	GS1

Premarket Submissions

Submission Number	Supplement Number
K141781	000