Question 1

What types of devices does Boston Medical Products, Inc. manufacture?

Accepted Answer

Boston Medical Products, Inc. manufactures trachea prostheses, laryngectomy tubes, polymeric laryngeal stents, intranasal splints (non-biodegradable), tracheostoma buttons, polymeric oesophageal stents (non-bioabsorbable), tracheostomy tube decannulation caps, and preformed vocal cord medialization implants. Example devices include the Montgomery® Salivary Bypass Tube, Montgomery® Initial Cannula Set, Montgomery® Laryngeal Keel, Montgomery® Safe-T-Tube™, Singer Laryngectomy Tube, and OTOCELL® Ear Wick.

The company's devices are classified as Class I, Class II, and unclassified (U) and are listed in the FDA UDI registry. Boston Medical Products, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Boston Medical Products, Inc. based?

Accepted Answer

Boston Medical Products, Inc. is based in the United States, as explicitly stated in the SUMMARY section of the device data. The COUNTRY field confirms this as US, indicating the company’s location without referencing any specific city, state, or facility details beyond the national level.

Question 3

In which regulatory registry are Boston Medical Products, Inc.'s devices listed?

Accepted Answer

Boston Medical Products, Inc.'s devices are listed in the FDA UDI registry, as indicated by the LISTED IN field in the device data. This refers to the U.S. Food and Drug Administration’s Unique Device Identification system, which tracks medical devices for regulatory purposes; the company itself is not approved or cleared—only individual devices may be authorised through this system.

Question 4

How are Boston Medical Products, Inc.'s devices classified?

Accepted Answer

Boston Medical Products, Inc.'s devices are classified as Class I, Class II, and unclassified (U), according to the DEVICE CLASSES field in the provided data. This classification reflects the risk-based regulatory framework used by the FDA, where Class I devices are low risk, Class II are moderate risk, and unclassified (U) devices have not been assigned a specific class; the company does not claim approval or clearance for any device, only that its products fall into these regulatory categories.

Device	Model / Reference	Registries	Class	Status
Montgomery® Salivary Bypass Tube	322180R	FDA UDI	Class I	Active
Montgomery® Initial Cannula Set	330800	FDA UDI	Class II	Active
Montgomery® Laryngeal Keel	323050R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	62010R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	520016	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-0927	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	460008R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	520011	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	62011R	FDA UDI	Class II	Active
OTOCELL® Ear Wick	EW-815	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	320006	FDA UDI	Class II	Active
HMS Lubricant Kit	82095	FDA UDI	Class II	Active
Montgomery® Thyroplasty Instrument Set	MT-200	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-0918	FDA UDI	Class I	Active
OTOSILK™ Graft Dressing	OT-4601	FDA UDI	Class I	Active
Singer Laryngectomy Tube	SLT-1227	FDA UDI	Class I	Active
Trach Tube Cleaning Brushes	3308	FDA UDI	Class I	Active
OTOCELL® Instrument Wipe	WP-881	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	62011R	FDA UDI	Class II	Active
Montgomery® Thyroplasty Implant Set	MTC-01	FDA UDI	Class II	Active
Montgomery® Thyroplasty Instrument	MT-207	FDA UDI	Class II	Active
Montgomery® Salivary Bypass Tube	322080R	FDA UDI	Class I	Active
OTOSILK™ Otological Strips	OT-16610	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	560013	FDA UDI	Class II	Active
Montgomery® Laryngeal Stent	323025	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	52012R	FDA UDI	Class II	Active
Moore Tube 15 mm Inner Cannula	MTT-006-CN	FDA UDI	Class II	Active
Montgomery® Thyroplasty Instrument	MT-213	FDA UDI	Class II	Active
15 mm Adaptor	321187	FDA UDI	Class II	Unknown
Montgomery® Thyroplasty Implant	MTM-10	FDA UDI	Class II	Active
Plug/Ring Set	321086	FDA UDI	Class II	Active
Montgomery® Salivary Bypass Tube	322200	FDA UDI	Class I	Active
Montgomery® Initial Cannula Set	330600	FDA UDI	Class II	Active
Plug/Ring Set	321066	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	460016R	FDA UDI	Class II	Active
Nasal Septal Button	60-101	FDA UDI	U	Active
Montgomery® Short-Term Cannula	330801	FDA UDI	Class II	Active
HMS System™	820007	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	62015R	FDA UDI	Class II	Active
Bivalve Nasal Splint, Large	60-304	FDA UDI	Class I	Active
Montgomery® Laryngeal Keel	323060	FDA UDI	Class II	Active
OTOSILK™ Otological Strips	OT-16610	FDA UDI	Class I	Active
15 mm Adaptor	321127	FDA UDI	Class II	Active
15 mm Adaptor	321107	FDA UDI	Class II	Active
Plug/Ring Set	321126	FDA UDI	Class II	Active
Cannula Faceplate	310403	FDA UDI	Class II	Active
Montgomery® Thyroplasty Instrument Set	MT-200	FDA UDI	Class II	Active
Montgomery® Thyroplasty Instrument	MT-209	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	520015	FDA UDI	Class II	Active
Trach Tube Cleaning Brushes	3304	FDA UDI	Class I	Active

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