FDA.report

n.a.

Primary DI
04048551322093
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13991CLE
Device description
Connector, for vent connection
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FDFColonoscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551322093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551322093040485513220934048551322093

GMDN Terms

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

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04953170467349ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-09-25
14547410477242FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477273FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477303FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04961333356478PENTAX MedicalHOYA CORPORATIONFDF2025-04-28
04961333129430PENTAXHOYA CORPORATIONFDF2025-04-04
04961333172085PENTAXHOYA CORPORATIONFDF2025-04-04
84953170463910BALLOON3OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-02-25
00850458007041GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16
04961333254620PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04953170465970EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FDF2024-11-25
06972520301094REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301100REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301117REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301124REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301179REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301186REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301193REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301209REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
04961333254781PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254460PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254811PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254477PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254798PENTAXHOYA CORPORATIONFDF2024-07-26
50724995228939DEFENDOMEDIVATORS INC.FDF2024-01-18
B369MES01019MEDISONOMedisono, LLCFDF2023-11-17
B369MES01020MEDISONOMedisono, LLCFDF2023-11-17
B369MES01021MEDISONOMedisono, LLCFDF2023-11-17