Single Use Surgical Professional

Basic Information

• Brand Name: Single Use Surgical Professional
• Primary DI: 05055299101186
• Version / Model: S044
• Catalog Number: S044
• Company Name: EAKIN SURGICAL LIMITED
• Labeler DUNS: 239505063
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 5
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 8ddf0555-3945-4e77-a7c1-1e7a9510a845
• Distribution End Date: 2023-10-24

Device Description

Tibbs Cannula Set of 3

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
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial	A semi-rigid or rigid tube intended to be surgically inserted into an artery to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055299101186	GS1
Package	05055299100417	GS1	Carton	25	Not in Commercial Distribution	2023-10-24

Customer Contacts

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