EKCOMED

Basic Information

• Brand Name: EKCOMED
• Primary DI: 00850000965010
• Version / Model: EKM-SR10B
• Catalog Number: EKM-SR10B
• Company Name: Ekcomed, LLC
• Labeler DUNS: 178249053
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 2
• Public Version Date: 2023-03-29
• Public Version Status: Update
• Public Device Record Key: 70fa213f-cd55-461a-b955-857251b1359a

Device Description

SUREtriever Suture Retriever

Device Characteristics

• Single Use: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTD	Forceps	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45717	Suture knot pusher, single-use	A hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850000965010	GS1
Unit of Use	10850000965017	GS1

Customer Contacts

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