FDA.report

USA Elite System™ Cysto-Resectoscope Spacer Use With USA Elite System

Primary DI
00821925003187
Brand
USA Elite System™ Cysto-Resectoscope Spacer Use With USA Elite System
Company
Gyrus Acmi, Inc.
Model
ESCR
Device description
ESCR Cysto-Resectoscope Spacer
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FGODISLODGER, STONE, FLEXIBLE

Product Code Classifications

CodeDeviceSpecialtyClass
FGODislodger, Stone, FlexibleGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821925003187PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00821925003187140082192500318708219250031870821925003187Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

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
Moist Heat or Steam Sterilization

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002098USA Elite SystemEOS-HCF252024-07-25
00821925002111USA Elite SystemERIS-CF252024-07-25
00821925002128USA Elite SystemERIS-CF272024-07-25
00821925002159USA Elite SystemERLB-7.52024-07-25
00821925002166USA Elite SystemEROS-CF252024-07-25
00821925002173USA Elite SystemEROS-CF272024-07-25
00821925002586Gyrus ACMI1942024-07-25
00821925007482Gyrus ACMIRFG-31152024-07-25
00821925008076Bovie5686012024-07-25
00821925008083Bovie5686042024-07-25
00821925008458Bovie5686052024-07-25
00821925008908Gyrus ACMIG2152-322024-07-25
00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

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00810116022915Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2020-02-18
00821925041349Gyrus ACMI, Inc.Gyrus Acmi, Inc.FGO2020-01-28
00810116020638Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00810116020645Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00810116020652Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGO2018-12-04
00821925007468Rigid Alligator Grasping Forceps Serrated Alligator Jaws 3 mm (9 Fr)Gyrus Acmi, Inc.FGO2016-10-18
00821925007956Rigid 3-Prong Grasper For Retrieval of Large Stone Fragments U-Type HGyrus Acmi, Inc.FGO2016-10-18
00821925001268USA Elite System™ Rigid Optical Stone Crushing ForcepsGyrus Acmi, Inc.FGO2016-10-13
00821925009509SURLOK Helical Stone Basket 1.9 FR (0.633 mm) X 120 cm Basket Width:Gyrus Acmi, Inc.FGO2016-10-12
00821925010673SURLOK Flat-Wire Stone Basket 2.4 FR (1.0mm) X 120 cm Basket Width:Gyrus Acmi, Inc.FGO2016-10-12
00821925027688X-Catch NT 3.0 Fr (1.00mm) x 115cm Stone Retrieval DeviceGyrus Acmi, Inc.FGO2016-10-05
00821925027695X-Catch NT 2.2 Fr (0.73mm) x 115cm Stone Retrieval DeviceGyrus Acmi, Inc.FGO2016-10-05
00821925027701Ultra-Catch NT 2.2 Fr (0.73mm) x 115cm Stone Retrieval DeviceGyrus Acmi, Inc.FGO2016-10-05
00821925027718Ultra-Catch NT 3.0 Fr (1.00mm) x 115cm Stone Retrieval DeviceGyrus Acmi, Inc.FGO2016-10-05
00821925027725Ultra-Catch NT 1.8 Fr (0.60mm) x 115cm Stone Retrieval DeviceGyrus Acmi, Inc.FGO2016-10-05
00821925028098X-Catch NT 1.8 Fr (0.60mm) x 115cm Stone Retrieval DeviceGyrus Acmi, Inc.FGO2016-10-05
00821925009394SURLOK Flat-Wire Stone Basket 3.0 FR (1.0 mm) X 70 cm Basket Width:Gyrus Acmi, Inc.FGO2016-10-03
00821925009417SURLOK Stone Grasping Forcpes 3.0 FR (1.0 mm) X 120 cm Basket Width:Gyrus Acmi, Inc.FGO2016-10-03