Single Use Surgical Professional

Basic Information

• Brand Name: Single Use Surgical Professional
• Primary DI: 05055299103623
• Version / Model: S224
• Catalog Number: S224
• Company Name: EAKIN SURGICAL LIMITED
• Labeler DUNS: 239505063
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 6
• Public Version Date: 2023-10-24
• Public Version Status: Update
• Public Device Record Key: e5c093e4-a56e-4d30-b273-af9071ca7902
• Distribution End Date: 2023-10-23

Device Description

Frazier Suction 15fg 9cm

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: Yes
• 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
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35917	Surgical/emergency suction cannula, non-illuminating, single-use	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. 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. Sometimes referred to as a 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 connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055299103623	GS1
Package	05055299103456	GS1	Carton	25	Not in Commercial Distribution	2023-10-23

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	9	Centimeter
Catheter Gauge	15	French