FDA.reportPublic FDA data

Luer Rongeur forceps

Primary DI
04049113104973
Brand
Luer Rongeur forceps
Company
EFER ENDOSCOPY
Model
411-548
Device description
Luer Rongeur forceps, diameter 8 mm, length 175 mm, for fenestration of silicone stents
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
04049113104973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049113104973040491131049734049113104973

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
286097451
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G006DJ4586SPEC142Lid for sterilization basketDJ-4586-SPEC2023-11-14
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

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