FDA.reportPublic FDA data

USA Elite

Primary DI
00821925003187
Brand
USA Elite
Company
Gyrus ACMI, LLC
Model
ESCR
Device description
USA Elite System Cysto-Resectoscope Spacer Use With USA Elite System Short Bridge, Rigid Forceps And Resectoscope Sheaths
Published
2016-10-14
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
FGODISLODGER, STONE, FLEXIBLE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925003187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925003187008219250031878219250031870821925003187

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic stone-retrieval forceps, reusableA rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

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
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