FDA.reportPublic FDA data

USA Elite

Primary DI
00821925008175
Brand
USA Elite
Company
Gyrus ACMI, LLC
Model
REXEBWE
Device description
USA Elite System Baumrucker Working Element
Published
2024-07-24
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, 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
00821925008175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008175008219250081758219250081750821925008175

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

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALFAS2026-07-10
08904148106339ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148106353ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148101402ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101525ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101570ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101587ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101600ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101617ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101624ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101822ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101839ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101846ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101853ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101860ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101877ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101891ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102157ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102164ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102379ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148103628ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105868ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105875ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105882ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106322ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106346ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21