FDA.reportPublic FDA data

ENTity XL Nasopharyngoscope

Primary DI
00858119004132
Brand
ENTity XL Nasopharyngoscope
Company
OPTIM LLC
Model
F014721
Device description
ENTity XL NasoView Flexible LED Nasopharyngoscope
Published
2020-04-23
Public version status
New
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
00858119004132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858119004132008581190041328581190041320858119004132

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
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
00858119004163ENTity SDXL 45X NasopharyngoscopeF0150502016-09-19
00858119004170ENTity XL (PA Compatible) NasopharyngoscopeF0152502017-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16