FDA.reportPublic FDA data

n.a.

Primary DI
04048438005408
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
011160-10
Catalog number
011160-10
Device description
Electrode, bipolar
Published
2024-10-04
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
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
FDCResectoscope, working element
FJLResectoscope
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
FDCResectoscope, Working ElementGastroenterology, Urology2
FJLResectoscopeGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048438005408PrimaryGS10
04048438005392Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048438005408040484380054084048438005408
04048438005392040484380053924048438005392

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Regulatory Flags#

DUNS number
315731430
Device count
10
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
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002154Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002154Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002161Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002161Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002178Active working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002178Active working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002185Passive working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002185Passive working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONFAS2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055573Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055573Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055597Rev360STRYKER CORPORATIONHIH2016-09-23