FDA.reportPublic FDA data

SILVER SCOPE

Primary DI
04048551003701
Brand
SILVER SCOPE
Company
Karl Storz GmbH & Co. KG
Model
13925PKS
Device description
Standard Colonoscope 3.8/1600 PAL
Published
2019-02-23
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
04048551003701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551003701040485510037014048551003701

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
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
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06973786293260Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293284Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293307Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293321Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293222Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
06973786293246Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15