FDA UDI
In Commercial Distribution
🇺🇸 United States
SonoInject Catheter HSG
DI: 00850011427187
·
Model: 61-2005 HSG
·
TITUS MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SonoInject Catheter HSG
- Primary DI
- 00850011427187
- Version / Model
- 61-2005 HSG
- Catalog Number
- 61-2005 HSG
- Company Name
- TITUS MEDICAL LLC
- Labeler DUNS
- 080306309
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-31
- Public Version
- 1
- Public Version Date
- 2024-04-08
- Public Version Status
- New
- Public Device Record Key
- 89d76a9b-7359-44a7-948b-15ca6bf11ce0
Device Description
SIS or HSG single Lumen Catheter 5fr
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15622 | Uterine injector | A hand-held manual device designed to inject/administer liquids into the uterus and/or fallopian tubes, typically contrast medium during radiographic procedures to evaluate tubal patency. It is typically used in conjunction with an appropriate intrauterine catheter which may be manipulated through an external mechanism. The injector may be used to manipulate or reposition the uterus during diagnostic and/or surgical procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850011427194 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00850011427187 | GS1 |
Customer Contacts
- Phone
- 888-550-6185
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092969 | 000 |