FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333225569
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
EB19-J10U
Device description
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Published
2020-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333222162Direct MarkingGS10
04961333225569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333222162049613332221624961333222162
04961333225569049613332255694961333225569

GMDN Terms#

Term, Definition table
TermDefinition
Flexible ultrasound bronchoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device typically through a fibreoptic bundle or a video system, and an ultrasound probe. The probe may be built-in or inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide
High-level Disinfectant

Regulatory Flags#

DUNS number
691519705
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333255528PENTAX MedicalOE-B92026-08-25
04961333256181PENTAXOF-B1902026-08-25
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14
04961333248209PENTAXEC38-i10L2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920684PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920899PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920929PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920950PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926389PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926419PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926426PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926464PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926808PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926815PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926822PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926839PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926846PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926877PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926884PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926891PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926976PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926983PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926990PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927003PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927164PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927218PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826928284PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04547410524642FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
04547410524680FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
06972084140634WiScope®Ningbo Wise Optomech Technology CorporationEOQ2026-07-28