Stronghold

Basic Information

• Brand Name: Stronghold
• Primary DI: 00860002529004
• Version / Model: SSDD
• Catalog Number: SSDD
• Company Name: HAMMER-PLANE INC
• Labeler DUNS: 791765001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-26
• Public Version: 1
• Public Version Date: 2019-10-04
• Public Version Status: New
• Public Device Record Key: d6dcbfd4-a6fa-4a60-a5b0-09cfeb1d987c

Device Description

Stronghold anti-disconnect device for Adult Shiley Flexible and Legacy tracheostomy tubes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
JAY	Support, Breathing Tube	Anesthesiology	868.5280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63438	Tracheostomy tube neck holder, single-use	A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not 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	00860002529004	GS1
Package	00860002529035	GS1	box	20	In Commercial Distribution