FDA.reportPublic FDA data

Stone Cone

Primary DI
08714729430223
Brand
Stone Cone
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0063903200
Device description
Nitinol Urological Retrieval Coil
Published
2016-09-24
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

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
08714729430223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729430223087147294302238714729430223

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
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
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

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
00810116022908Dornier 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