FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270966148
·
Model: R57422-VIP
·
ROCKET MEDICAL PLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270966148
- Version / Model
- R57422-VIP
- Catalog Number
- R57422-VIP
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-31
- Public Version
- 2
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- 022ce01b-bcbd-428a-b8db-f8c0ab7bdf8f
- Distribution End Date
- 2023-12-07
Device Description
Rocket 5Fg HSG Sonohystogram Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | Obstetrics/Gynecology | 884.1300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18746 | Intrauterine imaging medium catheter | A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270966155 | GS1 | Inner | 10 | Not in Commercial Distribution | 2023-12-07 |
| Primary | 05055270966148 | GS1 | ||||
| Package | 05055270966162 | GS1 | Outer | 35 | Not in Commercial Distribution | 2023-12-07 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000340 | 000 |