FDA.reportPublic FDA data

n.a.

Primary DI
04048551006320
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13991CD
Device description
Double valve channel splitter
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063585000KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEMKARL STORZ Endoscopy-America, Inc.2007-01-31FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551006320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551006320040485510063204048551006320

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical oesophagoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
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
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
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
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
04580826926112PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926150PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926228PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926273PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926280PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826927560PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928420PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928437PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25