FDA.reportPublic FDA data

n.a.

Primary DI
04048551056042
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13277TE
Device description
Spare Papillotome with Tubing
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
KGEFORCEPS, BIOPSY, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGEForceps, Biopsy, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551056042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551056042040485510560424048551056042

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). 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
06959664913871NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913888NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913895NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913901NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913918NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913925NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913932NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913949NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913956NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913963NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913970NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913987NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
04953170466038Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
08809327353293ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353316ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353323ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355518ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355808ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353290ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353313ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353320ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355515ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355805ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
04953170466243DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
04953170466250DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
06934415022309ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022316ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022323ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19