FDA.reportPublic FDA data

n.a.

Primary DI
04048551049587
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
10970BZ
Device description
Adaptor for 10970 BR
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04048551049587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551049587040485510495874048551049587

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope assembly adaptorA connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
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
04048551425718NAKarl Storz GmbH & Co. KGEWY2025-03-27
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
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