FDA.reportPublic FDA data

HYST 2,9/30/300 AK HD COVIDIEN

Primary DI
04035873071419
Brand
HYST 2,9/30/300 AK HD COVIDIEN
Company
Henke-Sass, Wolf GmbH
Model
8300057945
Catalog number
8300057945
Published
2022-12-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035873071419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035873071419040358730714194035873071419

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 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 typically 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317326411
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035873059776HSW HENKE-JECT®485000300048500030002020-12-09
04035873055549NA830003857183000385712017-08-04
04035873055556NA830003857283000385722017-08-04
04035873055563NA830003857383000385732017-08-04
04035873055570NA830003857483000385742017-08-04
04035873055587NA830003857583000385752017-08-04
04035873055594NA830003857683000385762017-08-04
04035873055600NA830003857883000385782017-08-04
04035873055617NA830003874583000387452017-08-04
04035873068709N/A830005352083000535202021-02-19
04035873068723N/A830005352283000535222021-02-19
04035873068730N/A830005352383000535232021-02-19
04035873069188N/A830005490883000549082021-02-19
04035873068679N/A830005351783000535172021-02-18
04035873068686N/A830005351883000535182021-02-18
04035873068693N/A830005351983000535192021-02-18
04035873068716N/A830005352183000535212021-02-18
04035873067788N/A830005474983000547492021-02-16
04035873066538N/A830005347583000534752021-02-12
04035873066569N/A830005347883000534782021-02-12

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