Rocket
- Primary DI
- 05055270974457
- Company
- ROCKET MEDICAL PLC
- Model
- R57424-VIP
- Catalog number
- R57424-VIP
- Device description
- Rocket HSG Catheter 7FG
- Published
- 2023-10-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 544313588
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05055270974457 | Package | GS1 | 10 | In Commercial Distribution |
| 05055270974464 | Package | GS1 | 35 | In Commercial Distribution |
| 05055270974440 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 05055270974457 | Package | GS1 | 10 | Inner | 05055270974440 | | In Commercial Distribution |
| 05055270974464 | Package | GS1 | 35 | Outer | 05055270974457 | | In Commercial Distribution |
| 05055270974440 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 2 | Obstetrics/Gynecology | 884.1300 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K000340 | 000 | HYSTALOG HSG CATHETER | Rocket Medical Plc | 2000-04-19 | HES |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
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