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ENTity SDXL Nasopharyngoscope

FDA UDI

Class II (US FDA UDI)

by Optim Llc

Identity

Trade Name
ENTity SDXL Nasopharyngoscope FDA UDI
Generic Name
Flexible fibreoptic nasopharyngoscope FDA UDI
Device Name
ENTity SDXL NasoView Flexible LED Nasopharyngoscope FDA UDI
Model / Reference
F015049 FDA UDI
Description
ENTity SDXL NasoView Flexible LED Nasopharyngoscope FDA UDI

Identifiers

Primary DI / UDI-DI
00858119004156 FDA UDI
510(k) Number
K080622 FDA UDI
FDA Product Code
EOB FDA UDI
GMDN Term
Flexible fibreoptic nasopharyngoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4760 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Flexible fibreoptic nasopharyngoscope

ENTity SDXL Nasopharyngoscope by Optim Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic nasopharyngoscope.

Cleared under the same submission

K080622 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Optim Llc

Sources (1)

  • FDA UDI 573fc1f9-fed6-4d00-a3df-e36ecc0e9c9f 34 fields · synced Jun 8, 2026