Home GUDID 00821925009813 SRLK,GRASPFCP,3.0,3W,120, HK,R
Primary DI 00821925009813
Brand SRLK,GRASPFCP,3.0,3W,120, HK,R
Company Gyrus Acmi, Inc.
Model 5720004
Published 2016-10-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FGO DISLODGER, STONE, FLEXIBLE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGO Dislodger, Stone, Flexible Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925009813 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00821925009813 00821925009813 821925009813 0821925009813
GMDN Terms# Term, Definition table Term Definition Flexible endoscopic stone-retrieval forceps, single-use A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a flexible metal coil or plastic tube whose distal end is equipped with a pair of thin grasping claws in which the stone is seized and held for extraction. The claws are operated by a control handle at the proximal end of the instrument. This is a single-use device.
Regulatory Flags# DUNS number 007198742 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00821925044326 Soltive Gyrus Acmi, Inc. FGO 2020-03-23 10724995182660 Falcon US Endoscopy FGO 2020-03-19 10724995182783 Talon US Endoscopy FGO 2020-03-19 00810116022304 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022311 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022328 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022335 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022342 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022359 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022366 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022373 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022908 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022915 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00821925041349 Gyrus ACMI, Inc. Gyrus Acmi, Inc. FGO 2020-01-28 00810116020638 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00810116020645 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00810116020652 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00821925007468 Rigid Alligator Grasping Forceps Serrated Alligator Jaws 3 mm (9 Fr) Gyrus Acmi, Inc. FGO 2016-10-18 00821925007956 Rigid 3-Prong Grasper For Retrieval of Large Stone Fragments U-Type H Gyrus Acmi, Inc. FGO 2016-10-18 00821925003187 USA Elite System™ Cysto-Resectoscope Spacer Use With USA Elite System Gyrus Acmi, Inc. FGO 2016-10-14 00821925001268 USA Elite System™ Rigid Optical Stone Crushing Forceps Gyrus Acmi, Inc. FGO 2016-10-13 00821925009509 SURLOK Helical Stone Basket 1.9 FR (0.633 mm) X 120 cm Basket Width: Gyrus Acmi, Inc. FGO 2016-10-12 00821925010673 SURLOK Flat-Wire Stone Basket 2.4 FR (1.0mm) X 120 cm Basket Width: Gyrus Acmi, Inc. FGO 2016-10-12 00821925027688 X-Catch NT 3.0 Fr (1.00mm) x 115cm Stone Retrieval Device Gyrus Acmi, Inc. FGO 2016-10-05 00821925027695 X-Catch NT 2.2 Fr (0.73mm) x 115cm Stone Retrieval Device Gyrus Acmi, Inc. FGO 2016-10-05 00821925027701 Ultra-Catch NT 2.2 Fr (0.73mm) x 115cm Stone Retrieval Device Gyrus Acmi, Inc. FGO 2016-10-05 00821925027718 Ultra-Catch NT 3.0 Fr (1.00mm) x 115cm Stone Retrieval Device Gyrus Acmi, Inc. FGO 2016-10-05 00821925027725 Ultra-Catch NT 1.8 Fr (0.60mm) x 115cm Stone Retrieval Device Gyrus Acmi, Inc. FGO 2016-10-05 00821925028098 X-Catch NT 1.8 Fr (0.60mm) x 115cm Stone Retrieval Device Gyrus Acmi, Inc. FGO 2016-10-05 00821925009394 SURLOK Flat-Wire Stone Basket 3.0 FR (1.0 mm) X 70 cm Basket Width: Gyrus Acmi, Inc. FGO 2016-10-03