Gyrus ACMI

Primary DI
00821925007468
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
RAG-337R
Device description
Rigid Alligator Grasping Forceps Serrated Alligator Jaws 3 mm (9 Fr), 37 cm
Published
2016-10-18
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
00821925007468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925007468008219250074688219250074680821925007468

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
00821925032774Gyrus ACMI145011-ENT2016-09-29
00821925032859Gyrus ACMI145007-ENT2016-09-29
00821925032903Gyrus ACMI145216-ENT2016-09-29
00821925034044Gyrus ACMI2220-2210-052016-10-11
00821925034853Gyrus ACMI7089-08442018-09-13
00821925034860Gyrus ACMI7089-08462018-09-13
00821925034877Gyrus ACMI7089-08482018-09-13
00821925034884Gyrus ACMI7089-08502018-09-13
00821925034891Gyrus ACMI7089-08522018-09-13
00821925034907Gyrus ACMI7089-08542018-09-13
00821925034938Gyrus ACMI7089-08362018-09-13
00821925034945Gyrus ACMI7089-08382018-09-13
00821925034969Gyrus ACMI7089-08422018-09-13
00821925035072Gyrus ACMI145010-ENT2015-10-24
00821925036383Gyrus ACMIE-9F2016-10-13
00821925037915GYRUS ACMI004942-9012016-10-07
00821925037960Gyrus ACMI1010-2110-052016-10-07
00821925037977Gyrus ACMI1120-4110-052016-10-07
00821925038325Gyrus ACMICS-G52016-10-13
00821925038349Gyrus ACMIE-1F2016-10-13

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
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