FDA.reportPublic FDA data

Elite 2 System

Primary DI
00821925003408
Brand
Elite 2 System
Company
Gyrus ACMI, LLC
Model
E2OS-CF25
Device description
Elite 2 System Continuous Flow Resectoscope Outer Sheath 25.6 Fr (8.5 mm)
Published
2016-10-13
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
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

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
00821925003408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925003408008219250034088219250034080821925003408

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
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONFAS2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055597Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055597Rev360STRYKER CORPORATIONFAS2016-09-23
07613327053777NASTRYKER CORPORATIONFAS2016-09-23
07613327053777NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONFAS2016-09-23
07613327053791NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONHIH2016-09-23
07613327053814NASTRYKER CORPORATIONFAS2016-09-23
07613327053814NASTRYKER CORPORATIONHIH2016-09-23
07613327053821NASTRYKER CORPORATIONHIH2016-09-23
07613327053845NASTRYKER CORPORATIONHIH2016-09-23
07613327053852NASTRYKER CORPORATIONHIH2016-09-23
07613327053852NASTRYKER CORPORATIONFAS2016-09-23
07613327053869NASTRYKER CORPORATIONHIH2016-09-23
07613327053869NASTRYKER CORPORATIONFAS2016-09-23
07613327053876NASTRYKER CORPORATIONHIH2016-09-23