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XprESS LoProfile

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
XprESS LoProfile FDA UDI
Generic Name
Nasal/paranasal balloon catheter FDA UDI
Device Name
ENT Dilation System 5x8mm FDA UDI
Model / Reference
MSB&LLF FDA UDI
Description
ENT Dilation System 5x8mm FDA UDI

Identifiers

Catalog Number
LPLF-205 FDA UDI
Primary DI / UDI-DI
00857326005031 FDA UDI
FDA Product Code
LRC FDA UDI
PNZ FDA UDI
GMDN Term
Nasal/paranasal balloon catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
874.4180 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Category: Nasal/paranasal balloon catheterEustachian catheter, single-use

XprESS LoProfile by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eustachian catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 3d21cf7e-cf68-491f-a6a9-8a3bbef58df7 34 fields · synced Jun 6, 2026