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Fentex

FDA UDI

Class I (US FDA UDI)

by FENTEX medical GmbH

Identity

Trade Name
FENTEX FDA UDI
Generic Name
ENT speculum holder FDA UDI
Device Name
Ear Speculum Holding Arm by Shea FDA UDI
Model / Reference
118800FX FDA UDI
Description
Ear Speculum Holding Arm by Shea FDA UDI

Identifiers

Catalog Number
118800FX FDA UDI
Primary DI / UDI-DI
04250407712358 FDA UDI
FDA Product Code
FWZ FDA UDI
GMDN Term
ENT speculum holder FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: ENT speculum holder

Fentex by FENTEX medical GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT speculum holder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FENTEX medical GmbH

Sources (1)

  • FDA UDI 9403ea3a-90ac-43c8-9828-a63f87304cf0 35 fields · synced Jun 8, 2026