FDA.reportPublic FDA data

n.a.

Primary DI
04048551102268
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
26182TD
Catalog number
26182TD
Device description
Changing Rod, ø 2.9 mm
Published
2019-02-23
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
NWWHysteroscope accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551102268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551102268040485511022684048551102268

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath exchange guideAn invasive device in the form of a thin, rigid rod intended to provide guidance for exchanging one endoscope sheath, which has been introduced into a patient, for another (e.g., exchange a transvaginal diagnostic sheath with an operative sheath). It is intended to be inserted into the lumen of the initial sheath to guide sheath retraction and remain in situ to guide replacement sheath introduction; the guide is removed once the replacement sheath is in place. 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
Premarket exempt
true
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
06975339628420Single-use Endoscopic ScissorsMacroLux Medical Technology Co., Ltd.NWW2026-07-03
06975339628635Single-use Endoscopic ScissorsMacroLux Medical Technology Co., Ltd.NWW2026-07-03
06975339628642Single-use Endoscopic ScissorsMacroLux Medical Technology Co., Ltd.NWW2026-07-03
06974880994343Omni® Hysteroscopic GrasperSuzhou AcuVu medical technology Co., Ltd.NWW2026-04-17
00190776420208MillenniumAvalign Technologies, Inc.NWW2026-04-16
05708265017881LiNA OperaScope™ Lasso LiNA Medical AGNWW2026-04-03
05708265017904LiNA OperaScopeTM LassoLiNA Medical AGNWW2026-04-03
05708265017928LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017942LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017980LiNA OperaScope™ ScissorsLiNA Medical AGNWW2026-04-03
00190776416379MillenniumAvalign Technologies, Inc.NWW2026-02-16
00850033976359HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
00198506087943ELMED INCORPORATEDELMED INCORPORATEDNWW2026-01-16
00190776410872MillenniumAvalign Technologies, Inc.NWW2025-09-15
00190776410544MillenniumAvalign Technologies, Inc.NWW2025-09-11
06976860690412OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690429OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690436OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690443OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690450OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690467OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690474OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690481OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690498OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690504OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690511OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690528OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690535OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690542OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28