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Montgomery® Laryngeal Keel

FDA UDI

Class II (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
Montgomery® Laryngeal Keel FDA UDI
Generic Name
Polymeric laryngeal stent FDA UDI
Device Name
Size: 12 mm; Type: Clear FDA UDI
Model / Reference
323040 FDA UDI
Description
Size: 12 mm; Type: Clear FDA UDI

Identifiers

Catalog Number
323040 FDA UDI
Primary DI / UDI-DI
EBES3230400 FDA UDI
510(k) Number
K842800 FDA UDI
FDA Product Code
FWN FDA UDI
GMDN Term
Polymeric laryngeal stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Polymeric laryngeal stent

Montgomery® Laryngeal Keel by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric laryngeal stent.

Cleared under the same submission

K842800 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Medical Products, Inc.

Sources (1)

  • FDA UDI a7ed26da-5b5f-4b03-9d3b-a996f37fbadc 38 fields · synced Jun 9, 2026