EKCOMED

Basic Information

• Brand Name: EKCOMED
• Primary DI: 00850000965058
• Version / Model: EKM-TBC1644
• Catalog Number: EKM-TBC1644
• 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: 02ad4aa9-1a80-4bf1-ad94-38a41e1f11d7

Device Description

TBC Shoulder Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44851	Limb/torso/head restraint, single-use	A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850000965058	GS1
Unit of Use	10850000965055	GS1

Customer Contacts

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