FDA.reportPublic FDA data

TRUCLEARTM

Primary DI
03596010529497
Brand
TRUCLEARTM
Company
Smith & Nephew, Inc.
Model
7211067
Catalog number
7211067
Device description
CALIBRATION INSERT DISPOSABLE
Published
2015-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
03596010529497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010529497035960105294973596010529497

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

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