Rocket
- Primary DI
- 05055270943149
- Brand
- Rocket
- Company
- ROCKET MEDICAL PLC
- Model
- R57491
- Catalog number
- R57491
- Device description
- Rocket Cervix Adaptor Large - 30mm
- Published
- 2017-01-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05055270921741 | Package | GS1 | 10 | In Commercial Distribution |
| 05055270943149 | Package | GS1 | 2 | In Commercial Distribution |
| 05055270900357 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05055270921741 | 05055270921741 | 5055270921741 |
| 05055270943149 | 05055270943149 | 5055270943149 |
| 05055270900357 | 05055270900357 | 5055270900357 |
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
| Type | Value | Unit |
|---|
| Outer Diameter | 30 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 101 KiloPascal | 101 KiloPascal | |
| Handling Environment Humidity | 1 Percent (%) Relative Humidity | 70 Percent (%) Relative Humidity | |
| Handling Environment Temperature | -5 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 101 KiloPascal | 101 KiloPascal | |
| Storage Environment Humidity | 1 Percent (%) Relative Humidity | 70 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -5 Degrees Celsius | 30 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +4401914196988 | gudid@rocketmedical.com |
Regulatory Flags
- DUNS number
- 544313588
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
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