FDA.reportPublic FDA data

n.a.

Primary DI
04048551057179
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13991LV
Device description
Suction valve, reusable
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
FDFColonoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551057179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551057179040485510571794048551057179

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction systemAn assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate.

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""Hydrogen Peroxide"", ""Ethylene Oxide"", ""Peracetic Acid""]"
Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

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
04048551411704NAUF101UF1012025-03-27
04048438006368n.a.030647-10030647-102020-01-11
04048438006429n.a.031529-10031529-102020-01-11
04048438006306n.a.031523-10031523-102019-02-23
04048551440148n.a.091010-10091010-102026-10-16
04048551444559n.a.091011-10091011-102026-10-16
04048551423226HD-VIEW11272VH11272VH2020-01-11
04048551423363HD-VIEW11272VHU11272VHU2020-01-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDF2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDF2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDF2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDF2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDF2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDF2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDF2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDF2026-10-16
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
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04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25