FDA.reportPublic FDA data

N/A

Primary DI
04961333230228
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
8860
Device description
Adaptable Tube
Published
2017-04-07
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
K944656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944656000OPTUS SINUSCOPES AND ACCESSORIESOptus, Inc.1995-01-26EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333230228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333230228049613332302284961333230228

GMDN Terms#

Term, Definition table
TermDefinition
Rigid nasopharyngoscopeAn endoscope with a rigid 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 relayed lens optics or a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

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