FDA.reportPublic FDA data

n.a.

Primary DI
04048551417348
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
091370-06
Device description
CMOS Video Esophagoscope SSU
Published
2020-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOXEsophagoscope (flexible or rigid)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551417348PrimaryGS10
04048551417355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551417348040485514173484048551417348
04048551417355040485514173554048551417355

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video oesophagoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a single-use device.

Regulatory Flags#

DUNS number
315731430
Device count
6
Lot or batch
true
Expiration date on label
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
04961333251766PENTAX MedicalHOYA CORPORATIONEOX2023-06-21
00860008795557EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2023-01-26
00860002356006EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2019-12-17
00874485003210UNITY 9100COGENTIX MEDICAL, INC.EOX2018-12-20
04048551178515n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178539n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178546n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190098n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190104n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190111n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
00874485002985EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
00874485003005EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
04048551001387n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001493n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001974n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047675n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047811n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047828n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047866n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047873n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047897n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047903n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047941n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047989n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047996n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048641n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048658n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551053591n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068762n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068786n.a.Karl Storz GmbH & Co. KGEOX2016-09-23