FDA.reportPublic FDA data

n.a.

Primary DI
04048551169629
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
496U
Device description
Fiber Optic Ureter Probe
Published
2018-08-24
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
FCSLight, catheter, fiberoptic, glass, ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCSLight, Catheter, Fiberoptic, Glass, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551169629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551169629040485511696294048551169629

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral transilluminator, reusableA flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for (trans)illumination to facilitate visualization of the ureter. It is used to aid dissection during laparoscopic and/or open abdominal surgery; sometimes it is referred to as illuminating catheter. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Liquid Chemical""]"

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
Lot or batch
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
04048551253687n.a.Karl Storz GmbH & Co. KGFCS2017-10-21
00827002161436BushCOOK INCORPORATEDFCS2016-09-24
00827002162624BushCOOK INCORPORATEDFCS2016-09-24
00827002167377BushCOOK INCORPORATEDFCS2016-09-24
00827002167452BushCOOK INCORPORATEDFCS2016-09-24
00827002167469BushCOOK INCORPORATEDFCS2016-09-24
00827002167476BushCOOK INCORPORATEDFCS2016-09-24
07613327061215InfraVisionSTRYKER CORPORATIONFCS2016-09-23
07613327174816IRISSTRYKER CORPORATIONFCS2016-09-23
37613327061216InfraVisionSTRYKER CORPORATIONFCS2016-09-23