Montgomery® Tracheal Fenestrator

Basic Information

• Brand Name: Montgomery® Tracheal Fenestrator
• Primary DI: EBES3410080
• Version / Model: 341008
• Catalog Number: 341008
• Company Name: Boston Medical Products, Inc.
• Labeler DUNS: 131855157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 3
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: ed7ca294-7bd7-45d5-bc7a-fa63f8c47e7b

Device Description

Size: 8

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 Unsafe
• 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
FZT	Cutter, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33906	Tracheotome	A knife-like, hand-held manual surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EBES3410080	HIBCC
Package	EBES3410081	HIBCC	Carton	1	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size: 8
Outer Diameter	10	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry