FDA.reportPublic FDA data

Lid for sterilization basket

Primary DI
G006DJ4586SPEC142
Brand
Lid for sterilization basket
Company
EFER ENDOSCOPY
Model
DJ-4586-SPEC
Device description
Lid for basket DJ-4561-SPEC (External dimensions: 770 x 250 mm)
Published
2023-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854414000DUMON/HARRELLBryan Corp.1986-03-12EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G006DJ4586SPEC142PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical bronchoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs. It is inserted through the mouth during the procedure called bronchoscopy. The inserted portion has an internal lumen sufficiently large to permit free respiration of the patient. The anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. It is used to diagnose lung infections, pneumonia, lung cancer, and allows physicians to view the upper regions of the lungs and take biopsies and samples of secretions. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
286097451
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049113104973Luer Rongeur forceps411-5482023-11-14
04250302227209Optical grasping forceps32-3230-430HM2023-11-14
04250302227216Optical stent removal forceps32-3230-430HM-SA2023-11-14
04250302227223Optical biopsy forceps32-3231RD-4-4302023-11-14
G006DJ40431621Sterilization basketDJ-40432023-11-14
G006DJ4046SPEC927Sterilzation basket with lidDJ-4046-SPEC2023-11-14
G006DJ4371178Sterilization basket with lidDJ-43712023-11-14
G006DJ45611715Sterilization basket without lidDJ-45612023-11-14
G006DJ4561SPEC1117Sterilization basket without lidDJ-4561-SPEC2023-11-14
G006DJ45861733Lid for sterilization basketDJ-48862023-11-14
G006DJ4928195Silicone matDJ-49282023-11-14
G006DJ4929197Silicone matDJ-49292023-11-14
03700620600006Endoscope connectorC42023-11-07
03700620600020Endoscope connectorC12023-11-07
03700620600037Silicone capBS2319-32023-11-07
03700620600044Silicone capBS2318-32023-11-07
03700620600051Silicone capBS2317-32023-11-07
03700620600068Silicone capBS2316-32023-11-07
03700620600082Silicone capBS2314-32023-11-07
03700620600105Silicone capBS2312-32023-11-07

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