FDA.reportPublic FDA data

USA Elite System

Primary DI
00821925002159
Brand
USA Elite System
Company
Gyrus ACMI, LLC
Model
ERLB-7.5
Device description
USA Elite System Resectoscope Laser Bridge
Published
2024-07-25
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
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00821925002159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925002159008219250021598219250021590821925002159

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscope laser couplerA device used to connect a laser delivery system [e.g., the articulating arm of a carbon dioxide (CO2) laser] and a laparoscope; providing a coincidence between the aiming beam and the treatment beam at the target site. It typically consists of a lens housing including a set of lenses, a laparoscope adaptor, and a sleeve. It is attached to the laser delivery system at the proximal end and to the laparoscope at the distal end, and the sleeve is placed inside the working channel of the laparoscope to provide a path for the laser. The device is typically used for a procedure using a laser type which wavelength is not appropriate for fibreoptic cable transmission. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
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
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
14042761085172OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085189OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085196OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085202OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085219OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085226OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085233OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085240OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085257OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085264OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085271OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085288OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085295OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085301OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085318OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31