Identity
- Trade Name
- Stradis Medical, LLC. FDA UDI
- Generic Name
- Hysterosonography/endometrial biopsy catheter FDA UDI
- Device Name
- Sonohysterography And Hysterosalpingography Catheters FDA UDI
- Model / Reference
- 944705 FDA UDI
- Description
- Sonohysterography And Hysterosalpingography Catheters FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7529447051 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Hysterosonography/endometrial biopsy catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Stradis Medical, LLC. by Stradis Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stradis Medical, Llc
Sources (1)
- FDA UDI d34c736f-ddb0-450f-970a-e0206719fab2 35 fields · synced Jun 1, 2026