Eu Mdr
Eu Md Class 1
On The Market
🇺🇸 United States
FemVue Saline-Air Device
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 10859500005001
- Basic UDI-DI Code
- 00859500005FSANY
- Reference
- FSA-205IW
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Femasys Inc.
Additional Description
FemVue is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter to instill saline-air contrast media during sono- hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity.
CND Nomenclature Codes
| Code | Description |
|---|---|
| U080102 | CATHETERS FOR HYSTEROSALPINGOGRAPHY |
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