FDA.reportPublic FDA data

USA Elite

Primary DI
00821925008168
Brand
USA Elite
Company
Gyrus ACMI, LLC
Model
REXEAWE
Device description
USA Elite System Accessory Working Element
Published
2017-05-11
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
FECOBTURATOR, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FECObturator, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890328000ADULT RESECTOSCOPECircon Video1990-02-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925008168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008168008219250081688219250081680821925008168

GMDN Terms#

Term, Definition table
TermDefinition
ResectoscopeAn endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
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
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207023303NARichard Wolf GmbHFEC2021-03-03
04250480106143NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-20
04250480106051NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106068NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106075NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106082NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106099NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106105NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106112NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106129NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106136NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106938NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106174NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-16
00821925003149USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925003156USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925003163USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925003170USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925001480USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925001497USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925001503USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925001510USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002296USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002302USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925002326USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002333USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002371USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002388USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002401USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925002418USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002425USA Elite Gyrus ACMI, LLCFEC2016-10-13