← Back to catalogue

Har-El Pharyngeal Tube

FDA UDI

Class I (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
Har-El Pharyngeal Tube FDA UDI
Generic Name
Polymeric oesophageal stent, non-bioabsorbable FDA UDI
Device Name
Size: 12 mm; Type: Clear FDA UDI
Model / Reference
355120 FDA UDI
Description
Size: 12 mm; Type: Clear FDA UDI

Identifiers

Catalog Number
355120 FDA UDI
Primary DI / UDI-DI
EBES3551200 FDA UDI
510(k) Number
K923355 FDA UDI
FDA Product Code
KCF FDA UDI
GMDN Term
Polymeric oesophageal stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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 — 183 Millimeter FDA UDI
Outer Diameter — 12 Millimeter FDA UDI

Category: Polymeric oesophageal stent, non-bioabsorbable

Har-El Pharyngeal Tube by Boston Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric oesophageal stent, non-bioabsorbable.

Cleared under the same submission

K923355 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Medical Products, Inc.

Sources (1)

  • FDA UDI c266eed2-1c3f-48ce-aeae-601bbc830d89 38 fields · synced Jun 9, 2026