FDA.reportPublic FDA data

Hysteroscopic Fluid Management System Stand

Primary DI
03596010529541
Brand
Hysteroscopic Fluid Management System Stand
Company
Smith & Nephew, Inc.
Model
7210165
Catalog number
7210165
Device description
HYST. FLUID MGMT STAND
Published
2015-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIGINSUFFLATOR, HYSTEROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031616000IUR FLUID MANAGEMENT SYSTEMW.O.M. World of Medicine AG2003-08-13HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010529541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010529541035960105295413596010529541

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
045483575
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010469182GENESIS II71421012714210122015-08-30
03596010469212GENESIS II71421015714210152015-08-30
03596010469229GENESIS II71421016714210162015-08-30
03596010469236GENESIS II71421017714210172015-08-30
03596010469267GENESIS II71421112714211122015-08-30
03596010469274GENESIS II71421113714211132015-08-30
03596010469281GENESIS II71421114714211142015-08-30
03596010469298GENESIS II71421115714211152015-08-30
03596010469304GENESIS II71421116714211162015-08-30
03596010469328GENESIS II71421118714211182015-08-30
03596010531018JOURNEY74024629740246292015-08-29
03596010531025JOURNEY74024632740246322015-08-29
03596010554468JOURNEY74024623740246232015-08-29
03596010554475JOURNEY74024626740246262015-08-29
03596010554512JOURNEY74024826740248262015-08-29
03596010554529JOURNEY74024829740248292015-08-29
03596010554536JOURNEY74024832740248322015-08-29
03596010000675OXINIUM71343603713436032015-08-30
03596010469199GENESIS II71421013714210132015-08-30
03596010469205GENESIS II71421014714210142015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506023348Asurys™BOSTON SCIENTIFIC CORPORATIONHIG2026-04-03
00191506047962Asurys™BOSTON SCIENTIFIC CORPORATIONHIG2026-04-03
00850006759835Aveta Tissue Catch with TubingMEDITRINA, INC.HIG2026-03-20
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedMinerva Surgical, Inc.HIG2026-02-13
03700111401099RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401105RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401112RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401129RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
03700111401136SLIDING RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401143SLIDING RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401150SLIDING RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401167SLIDING RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
00850033976335Symphion Operative Hysteroscopy System Prime ControllerMinerva Surgical, Inc.HIG2025-10-31
00850006759811Aveta Drape PumpMEDITRINA, INC.HIG2025-04-11
07613327626391ThermaClearSTRYKER CORPORATIONHIG2025-04-04
07613327626407ThermaClearSTRYKER CORPORATIONHIG2025-04-04
04048551377567NAKarl Storz GmbH & Co. KGHIG2025-03-27
00821925002630Gyrus ACMIGyrus ACMI, LLCHIG2024-12-09
25420045516110Fluent Pro Waste BagHologic, Inc.HIG2024-10-15
25420045516134Fluent Pro Tissue TrapHologic, Inc.HIG2024-10-15
15420045516144Fluent Pro Procedure KitHologic, Inc.HIG2024-10-15
00850006759699Aveta Waste Management AccessoryMEDITRINA, INC.HIG2024-10-14
00850006759736Aveta Waste Bag with Tissue CatchMEDITRINA, INC.HIG2024-10-14
00850033976243Symphion Fluid Deficit ReadoutMinerva Surgical, Inc.HIG2024-08-12
15420045516212Fluent Pro Fluid Management SystemHologic, Inc.HIG2024-08-06
04056702012861GYN-PumpW.O.M. World of Medicine GmbHHIG2024-06-28
04056702012878Fluid Monitoring UnitW.O.M. World of Medicine GmbHHIG2024-06-28
00850006759460Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
00850006759484Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
00850006759613Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26