n.a.

Primary DI
04048551390146
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27023TD
Catalog number
27023TD
Device description
Stone Basket, 2.5 Fr., tip, helical
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBOCYSTOURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945185000CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)KARL STORZ Endoscopy-America, Inc.1995-05-03FBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551390146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551390146040485513901464048551390146

GMDN Terms#

Term, Definition table
TermDefinition
Biliary/urinary stone retrieval basket, reusableA flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14242188201regulatory@karlstorz.com

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
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
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04055207066225E-LINERichard Wolf GmbHFBO2020-02-21
04055207066195E-LINERichard Wolf GmbHFBO2020-02-21
04055207066201E-LINERichard Wolf GmbHFBO2020-02-21
04048551327746n.a.Karl Storz GmbH & Co. KGFBO2019-02-23
04048551390139n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390160n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390184n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390238n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390177n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
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