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
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
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