FDA.reportPublic FDA data

n.a.

Primary DI
04048551390153
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27023TF
Device description
Stone Basket, 3 Fr., w/ tip, helical
Published
2018-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGCURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGCUrethroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551390153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551390153040485513901534048551390153

GMDN Terms#

Term, Definition table
TermDefinition
Stone/foreign-body extraction setA collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
true
Expiration date on label
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
04048551075333n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551073681n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075272n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075296n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075319n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
00855308006021DirectVisionPERCUVISION LLCFGC2016-09-23
00855308006038DirectVisionPERCUVISION LLCFGC2016-09-23
04042761077491OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077507OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077545OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077569OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077576OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077729OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21