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® Thyroplasty Instrument	MT-202	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-1155	FDA UDI	Class I	Active
Singer Laryngectomy Tube	SLT-0827	FDA UDI	Class I	Active
Trach Tube Cleaning Brushes	3306	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	460015	FDA UDI	Class II	Active
Trach Tube Cleaning Brushes	3308	FDA UDI	Class I	Active
Singer Laryngectomy Tube	SLT-1127	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	71008R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	42013R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	42010R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	62012R	FDA UDI	Class II	Active
Montgomery® Salivary Bypass Tube	322100	FDA UDI	Class I	Active
Singer Laryngectomy Tube	SLT-1455	FDA UDI	Class I	Active
Montgomery® Laryngeal Stent	323020	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	460011R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	42016R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	42014R	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	52013R	FDA UDI	Class II	Active
Montgomery® Nerve Stimulator Accessories	MNS700	FDA UDI	Class II	Unknown
Epi-Max™ Epistaxis Procedure Pack	60-402	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	520016	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	420016	FDA UDI	Class II	Active
Cannula Faceplate	310603	FDA UDI	Class II	Active
Montgomery® Salivary Bypass Tube	322080	FDA UDI	Class I	Active
Montgomery® Long-Term Cannula	330641	FDA UDI	Class II	Active
Epi-Max™ Epistaxis Procedure Pack	60-402L	FDA UDI	Class I	Active
Montgomery® Thyroplasty Instrument	MT-205	FDA UDI	Class II	Active
RHINOCELL® Sinus Packing	SP-350912	FDA UDI	Class I	Active
Montgomery® Salivary Bypass Tube	322100R	FDA UDI	Class I	Active
Montgomery® Thyroplasty Implant	MTF-07	FDA UDI	Class II	Active
Montgomery® Salivary Bypass Tube	322180R	FDA UDI	Class I	Active
Montgomery® STOMEASURE™	STM100	FDA UDI	Class I	Active
Montgomery® Thyroplasty Instrument Set	MT-200P	FDA UDI	Class II	Active
Salman FES Stent	SS2000	FDA UDI	Class I	Active
Moore Tracheostomy Tube	MTT-006	FDA UDI	Class II	Active
Plug/Ring Set	321186	FDA UDI	Class II	Unknown
Montgomery® Thyroplasty Instrument	MT-210	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-1627	FDA UDI	Class I	Active
Montgomery® Esophageal Tube	322000	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	420010	FDA UDI	Class II	Active
Montgomery® Long-Term Cannula	330649	FDA UDI	Class II	Active
Montgomery® Thyroplasty Measuring Kit	MT-400	FDA UDI	Class II	Active
Montgomery® Tracheostomy Speaking Valve	221202	FDA UDI	Class II	Active
Cannula Faceplate	311003	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	420012	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	71008R	FDA UDI	Class II	Active
Montgomery® Thyroplasty Implant	MTM-08	FDA UDI	Class II	Active
Montgomery® Long-Term Cannula	330425	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-1636	FDA UDI	Class I	Active
Montgomery® Long-Term Cannula	330449	FDA UDI	Class II	Active

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