FDA.reportPublic FDA data

ENTity SDXL 45X Nasopharyngoscope

Primary DI
00858119004163
Brand
ENTity SDXL 45X Nasopharyngoscope
Company
OPTIM LLC
Model
F015050
Device description
ENTity SDXL 45X NasoView Flexible LED Nasopharyngoscope
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080622000ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105Optim, Inc.2008-04-02EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858119004163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858119004163008581190041638581190041630858119004163

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic nasopharyngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
052927001
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858119004194Entity XL Plus NasopharyngoscopeF0156952024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeF0156922024-06-19
00858119004217Entity XL USB NasopharyngoscopeF0162112024-06-19
00858119004101Portable Light SourceF0063873L12016-09-19
00858119004132ENTity XL NasopharyngoscopeF0147212020-04-23
00858119004019ENT 3.6FL30 Nasopharyngoscope408A6532016-09-19
00085119004132ENTity XL NasopharyngoscopeF0147212016-09-19
00858119004002ENTity NasopharyngoscopeF0061892016-09-16
00858119004026ENT 3.6FP30 NasopharyngoscopeF0054942016-09-19
00858119004125ENTity SD NasopharyngoscopeF0147662016-09-19
00858119004149ENTity SD 45X NasopharyngoscopeF0149012016-09-19
00858119004156ENTity SDXL NasopharyngoscopeF0150492016-09-19
00858119004170ENTity XL (PA Compatible) NasopharyngoscopeF0152502017-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16
07613327632774N/ASTRYKER CORPORATIONEOB2026-06-16
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041523InstaClearGyrus ACMI, LLCEOB2024-04-22
04961333239825VIVIDEOHOYA CORPORATIONEOB2024-02-07
07290016539226Colibri micro-ENT Scope3NT MEDICAL LTDEOB2023-12-31
04961333070367PENTAXHOYA CORPORATIONEOB2023-07-31
04961333075164PENTAXHOYA CORPORATIONEOB2023-07-31
04961333077984PENTAXHOYA CORPORATIONEOB2023-07-31
04961333084562PENTAXHOYA CORPORATIONEOB2023-07-31
04961333134052PENTAXHOYA CORPORATIONEOB2023-07-31
04961333134359PENTAXHOYA CORPORATIONEOB2023-07-31
04961333171262PENTAXHOYA CORPORATIONEOB2023-07-31
04961333221073PENTAX MedicalHOYA CORPORATIONEOB2023-07-31
04961333221448PENTAX MedicalHOYA CORPORATIONEOB2023-07-31
04961333221455PENTAX MedicalHOYA CORPORATIONEOB2023-07-31