DEVICE: NA (04250480103128)
Device Identifier (DI) Information
NA
41.1005a
In Commercial Distribution
SCHÖLLY FIBEROPTIC GmbH
41.1005a
In Commercial Distribution
SCHÖLLY FIBEROPTIC GmbH
Hysteroscope/Cystoscope 4 x 298 mm, 0°
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Rigid fibreoptic hysteroscope | An 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FAJ | Cystoscope And Accessories, Flexible/Rigid |
HIH | Hysteroscope (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Insertion tube outer diameter 4 mm |
Device Size Text, specify: Working length 298 mm |
Device Size Text, specify: Direction of view 0 Degree |
Device Record Status
4105045f-90c6-44ef-8367-cfed02ac44b8
March 29, 2018
2
November 11, 2016
March 29, 2018
2
November 11, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9999999999
info@schoelly-usa.com
info@schoelly-usa.com