FDA.reportPublic FDA data

NA

Primary DI
04048551425718
Brand
NA
Company
Karl Storz GmbH & Co. KG
Model
10973HD
Catalog number
10973HD
Device description
Video Mediastinoscope
Published
2025-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWYMediastinoscope, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWYMediastinoscope, SurgicalEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551425718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551425718040485514257184048551425718

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical mediastinoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+14242188201regulatory@karlstorz.com

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
true
Manufacturing date on label
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
24026704715293PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715309PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715316PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715323PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715330PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
00863189000311Aegis Illuminated Mediastinal Access Port AEGIS SURGICAL LIMITEDEWY2017-03-14
00863189000304Aegis Illuminated Mediastinal Access PortAEGIS SURGICAL LIMITEDEWY2017-03-14
10863189000318Aegis Illuminated Mediastinal Access Port AEGIS SURGICAL LIMITEDEWY2017-03-14
00814334021644NARichard Wolf GmbHEWY2016-09-30
04055207001097NARichard Wolf GmbHEWY2016-09-26
04055207009284NARichard Wolf GmbHEWY2016-09-26
04055207014806NARichard Wolf GmbHEWY2016-09-26
04055207020623NARichard Wolf GmbHEWY2016-09-26
04048551049587n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049594n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049570n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225387n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225424n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551242889DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04048551322062DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04055207000014NARichard Wolf GmbHEWY2016-09-23
04055207009260NARichard Wolf GmbHEWY2016-09-23
04055207020616NARichard Wolf GmbHEWY2016-09-23
04055207020630NARichard Wolf GmbHEWY2016-09-23
04055207020647NARichard Wolf GmbHEWY2016-09-23
04055207034071NARichard Wolf GmbHEWY2016-09-23
04055207034088NARichard Wolf GmbHEWY2016-09-23
04055207034095NARichard Wolf GmbHEWY2016-09-23
04055207034101NARichard Wolf GmbHEWY2016-09-23
04055207056400NARichard Wolf GmbHEWY2016-09-23