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Rutter Stent

FDA UDI

Class II (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
Rutter Stent FDA UDI
Generic Name
Polymeric laryngeal stent FDA UDI
Device Name
Size: 6 mm; Type: Radiopaque FDA UDI
Model / Reference
840006 FDA UDI
Description
Size: 6 mm; Type: Radiopaque FDA UDI

Identifiers

Catalog Number
840006 FDA UDI
Primary DI / UDI-DI
EBES8400060 FDA UDI
510(k) Number
K091135 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

Dimensions & Sizes

Size
Length — 83 Millimeter FDA UDI
Outer Diameter — 6 Millimeter FDA UDI

Category: Polymeric laryngeal stent

Rutter Stent 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

K091135 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 d12372d2-c69c-4705-a5eb-f9f5f8f1e14f 38 fields · synced Jun 9, 2026