FDA.reportPublic FDA data

NA

Primary DI
04048551225523
Brand
NA
Company
Karl Storz GmbH & Co. KG
Model
11001BI1
Device description
AF Broncho-Fiberscope 5.0x54
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRKSystem, Imaging, Fluorescence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRKSystem, Imaging, FluorescenceUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020008000KARL STORZ AUTOFLUORESCENCE SYSTEMKARL STORZ Endoscopy-America, Inc.2002-12-12MRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551225523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551225523040485512255234048551225523

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic 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 through a fibreoptic bundle. This device 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
"[""Liquid Chemical"", ""High-level Disinfectant"", ""Ethylene Oxide""]"

Contacts#

Phone, Email table
PhoneEmail
424-218-8201su.chen@karlstorz.com

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551225714NAKarl Storz GmbH & Co. KGMRK2014-09-24
04048551225776NAKarl Storz GmbH & Co. KGMRK2014-09-24