ENTity SDXL Nasopharyngoscope

GUDID 00858119004156

ENTity SDXL NasoView Flexible LED Nasopharyngoscope

OPTIM LLC

Flexible fibreoptic nasopharyngoscope
Primary Device ID00858119004156
NIH Device Record Key573fc1f9-fed6-4d00-a3df-e36ecc0e9c9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameENTity SDXL Nasopharyngoscope
Version Model NumberF015049
Company DUNS052927001
Company NameOPTIM LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858119004156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

Devices Manufactured by OPTIM LLC

00858119004132 - ENTity XL Nasopharyngoscope2020-05-01 ENTity XL NasoView Flexible LED Nasopharyngoscope
00858119004019 - ENT 3.6FL30 Nasopharyngoscope2020-04-24 ENT 3.6FL30 Flexible Nasopharyngoscope
00085119004132 - ENTity XL Nasopharyngoscope2020-04-24 ENTity XL NasoView Flexible LED Nasopharyngoscope
00858119004101 - Portable Light Source2019-02-21 LED Portable Light Source
00858119004002 - ENTity Nasopharyngoscope2018-07-06 ENTity Nasoview Flexible LED Nasopharyngoscope
00858119004026 - ENT 3.6FP30 Nasopharyngoscope2018-07-06 ENT 3.6FP30 Flexible Nasopharyngoscope
00858119004125 - ENTity SD Nasopharyngoscope2018-07-06 ENTity SD NasoView Flexible LED Nasopharyngoscope
00858119004149 - ENTity SD 45X Nasopharyngoscope2018-07-06 ENTity SD 45X NasoView Flexible LED Nasopharyngoscope

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