Identity
- Trade Name
- SonoInject Catheter HSG FDA UDI
- Generic Name
- Uterine injector FDA UDI
- Device Name
- SIS or HSG single Lumen Catheter 5fr FDA UDI
- Model / Reference
- 61-2005 HSG FDA UDI
- Description
- SIS or HSG single Lumen Catheter 5fr FDA UDI
Identifiers
- Catalog Number
- 61-2005 HSG FDA UDI
- Primary DI / UDI-DI
- 00850011427187 FDA UDI
- 510(k) Number
- K092969 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Uterine injector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Uterine injector
SonoInject Catheter HSG by Titus Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092969 also covers:
- 1 HSG/SIS Tray No Catheter — TITUS MEDICAL LLC
- 10 HSG/SIS Procedure Trays — TITUS MEDICAL LLC
- CUSTOM ASSEMBLIES HSG — TITUS MEDICAL LLC
- H/S Catheter — TITUS MEDICAL LLC
- H/S Catheter — TITUS MEDICAL LLC
- H/S Catheter — TITUS MEDICAL LLC
- H/S Catheter — TITUS MEDICAL LLC
- HSG Catheter — TITUS MEDICAL LLC
- HSG Catheter — TITUS MEDICAL LLC
- HSG Catheter — TITUS MEDICAL LLC
- HSG Catheter — TITUS MEDICAL LLC
- HSG Catheter — TITUS MEDICAL LLC
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 |
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Manufacturer
- Manufacturer
- Titus Medical Llc
Sources (1)
- FDA UDI 89d76a9b-7359-44a7-948b-15ca6bf11ce0 36 fields · synced Jun 8, 2026