FDA.reportPublic FDA data

n.a.

Primary DI
04048551405611
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
24911EL
Device description
Insert with channel
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
GCFPROCTOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCFProctoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551405611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551405611040485514056114048551405611

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
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
04048551084724n.a.Karl Storz GmbH & Co. KGGCF2018-08-21
04048551265420n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265437n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265444n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265475n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265499n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265505n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314500n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314524n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314555n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551229378n.a.Karl Storz GmbH & Co. KGGCF2017-10-20
04048551083307n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083390RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083420RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083628RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083666RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083727TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083741TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083840n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083888n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083901n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083956n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083970n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083994n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084014TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084038TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084090TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084113TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084168n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084434n.a.Karl Storz GmbH & Co. KGGCF2016-09-23