FDA.reportPublic FDA data

TRUCLEARTM Operative Hysteroscope 5.0

Primary DI
03596010654892
Brand
TRUCLEARTM Operative Hysteroscope 5.0
Company
Smith & Nephew, Inc.
Model
72202976
Catalog number
72202976
Device description
TRUCLEAR OPERATIVE HYSTEROSCOPE 5.0
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010654892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010654892035960106548923596010654892

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical hysteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00885556165560NA76515310765153102026-07-16
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00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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