DEVICE: Rocket (05055270913739)
Device Identifier (DI) Information
Rocket
R57424
In Commercial Distribution
R57424
ROCKET MEDICAL PLC
R57424
In Commercial Distribution
R57424
ROCKET MEDICAL PLC
Rocket 7Fg HSG Sonohystogram Catheter
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K000340 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 30.0 Centimeter |
Catheter Gauge: 7.0 French |
Device Record Status
05700981-3838-4604-9b2a-4b2ddf9ff1ee
July 06, 2018
3
September 02, 2016
July 06, 2018
3
September 02, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05055270935120 | 10 | 05055270913739 | In Commercial Distribution | ||
05055270956521 | 20 | 05055270935120 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401914196988
gudid@rocketmedical.com
gudid@rocketmedical.com