FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116022908
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
1.5Fr x 120cm,11mm Open Tip
Catalog number
BVEN11211
Device description
Nitonol Stone Extractor, 1.5Fr x 120cm,11mm Open Tip
Published
2020-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGODislodger, Stone, Flexible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGODislodger, Stone, FlexibleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116022908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116022908008101160229088101160229080810116022908

GMDN Terms#

Term, Definition table
TermDefinition
Urinary stone retrieval basket, single-useA manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130789944
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810116023387Dornier Axis IIDornier AXIS II E URS FLEX EU - UreteroscopeAX204082026-05-06
00810116023400Dornier MedTechDornier AXIS II D URS FLEX EU - UreteroscopeAX204132026-05-06
00810116023424Dornier MedTechDornier AXIS II CYSTO FLEX EU - UreteroscopeAX204102026-05-06
00810116023578Dornier MedTechDornier AXIS II Slim URS FLEX EU - UreteroscopeAX204162026-05-06
00810116023721Dornier MedTech Dornier Vesta Nitinol ExtractorIVX-US-F11102026-04-21
00810116023738Dornier MedTech Dornier Ceres Nitinol ExtractorIVX-US-T08102026-04-21
00810116023745Dornier MedTech Dornier Ceres Nitinol ExtractorIVX-US-T11102026-04-21
00810116023943Dornier MedTech Dornier FalconIVX-GF1-1808A2026-04-17
00810116024056Dornier MedTech AXIS II Clerix Suction URS Reverse DeflectionAX204182026-03-26
00810116024070Dornier MedTech AXIS II Clerix Suction URSAX204192026-03-26
00810116024094Dornier MedTech AXIS II Clerix Suction URSAX204202026-03-26
00810116024117Dornier MedTech AXIS II Clerix Suction URSAX204212026-03-26
00810116024049Dornier MedTech AXIS II Portable MonitorAX201002026-03-24
00810116023769Dornier HOOVER Access SheathIVX-NB-150IVX-NB-1502026-01-14
00810116023370Dornier MedTech Axis II Video ProcessorAX204072026-01-22
00810116023417Dornier MedTechDornier AXIS II D URS FLEX US - UreteroscopeAX204142026-01-22
00810116023431Dornier MedTechDornier AXIS II CYSTO FLEX US - UreteroscopeAX204112026-01-22
00810116023523Axis IIDornier AXIS II E URS FLEX US - UreteroscopeAX204092026-01-22
00810116023585Dornier MedTechAXIS II URS SLIM 7.5 FLEX SU USAX204172026-01-22
00810116023608Dornier HOOVER Access SheathIVX-NS-1040IVX-NS-10402026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925044326SOLTIVEGyrus ACMI, LLCFGO2020-03-23
00724995182663FalconUS EndoscopyFGO2020-03-19
00724995182786TalonUS EndoscopyFGO2020-03-19
10724995182660FalconUS EndoscopyFGO2020-03-19
10724995182783TalonUS EndoscopyFGO2020-03-19
00810116022304Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022311Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022328Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022335Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022342Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022359Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022366Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022373Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00810116022915Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00821925041349OLYMPUSGyrus ACMI, LLCFGO2020-01-28
00810116020577Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00810116020584Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00810116020591Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00810116020638Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00810116020645Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00810116020652Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00821925007468Gyrus ACMIGyrus ACMI, LLCFGO2016-10-18
00821925007956Gyrus ICMIGyrus ACMI, LLCFGO2016-10-18
00821925003187USA EliteGyrus ACMI, LLCFGO2016-10-14
00821925001268USA Elite Gyrus ACMI, LLCFGO2016-10-13
00821925009509GYRUS ACMIGyrus ACMI, LLCFGO2016-10-12
00821925010673GYRUS ACMIGyrus ACMI, LLCFGO2016-10-12
00821925027688OLYMPUSGyrus ACMI, LLCFGO2016-10-05
00821925027695OLYMPUSGyrus ACMI, LLCFGO2016-10-05
00821925027701OLYMPUSGyrus ACMI, LLCFGO2016-10-05