HORSESHOE ET Tube Securement Device

Basic Information

• Brand Name: HORSESHOE ET Tube Securement Device
• Primary DI: 00860013007607
• Version / Model: HS1
• Catalog Number: HS1
• Company Name: Surgicure Technologies, Inc.
• Labeler DUNS: 117605066
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-03
• Public Version: 2
• Public Version Date: 2026-01-06
• Public Version Status: Update
• Public Device Record Key: 40bd2467-fe8b-4204-b940-592cf16f322e
• Distribution End Date: 2025-10-31

Device Description

Endotracheal Tube Securement Device

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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	868.5770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35815	Endotracheal tube holder	A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860013007614	GS1	Case	10	Not in Commercial Distribution	2025-10-31
Primary	00860013007607	GS1

Customer Contacts

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