FDA.reportPublic FDA data

n.a.

Primary DI
04048551077603
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27050EL
Device description
Laser-Telescope Bridge
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
FJLRESECTOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551077603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551077603040485510776034048551077603

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
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;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
04048551161005n.a.408001102018-09-04
04048551291030NAV1408100202018-08-23
04048551325971n.a.408000212016-09-23
04048551160992n.a.408000902016-09-23
04048551277577n.a.408120202018-08-21
04048551325988n.a.408000512016-09-23
04048551336854NAV1408200202018-08-23
04048551337707n.a.408200862018-08-17
04048551337820NAV1408200302018-08-23
04048551271087n.a.408001202016-09-23
04048551387344n.a.408201232019-02-23
04048551387368n.a.408201502017-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207048788NARichard Wolf GmbHFJL2026-05-13
04055207071717PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071731PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071724PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071748PIRANHARichard Wolf GmbHFJL2025-11-17
00848657077507AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2025-08-25
04048551411704NAKarl Storz GmbH & Co. KGFJL2025-03-27
00860011104438VeloxionAulea Medical Inc.FJL2025-01-03
00860011104407VeloxionAulea Medical Inc.FJL2025-01-03
00860011104414VeloxionAulea Medical Inc.FJL2025-01-03
00860011104421VeloxionAulea Medical Inc.FJL2025-01-03
00860011104483VeloxionAulea Medical Inc.FJL2025-01-03
00860011104445VeloxionAulea Medical Inc.FJL2025-01-03
00860011104452VeloxionAulea Medical Inc.FJL2025-01-03
04048438005408n.a.Karl Storz GmbH & Co. KGFJL2024-10-04
04055207007822NARichard Wolf GmbHFJL2024-08-19
04055207008393NARichard Wolf GmbHFJL2024-08-19
04055207058985NARichard Wolf GmbHFJL2024-08-19
04055207069936NARichard Wolf GmbHFJL2024-08-19
04055207011911NARichard Wolf GmbHFJL2024-08-19
04055207038673NARichard Wolf GmbHFJL2024-04-01
04055207069783NARichard Wolf GmbHFJL2024-04-01
04055207057322SHARKRichard Wolf GmbHFJL2024-03-29
04055207055106PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207055113PANOVIEWRichard Wolf GmbHFJL2023-08-03
14042761085493OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085530OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085547OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085554OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085561OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27