DEVICE: Rocket (05055270913678)
Device Identifier (DI) Information
Rocket
R57405
In Commercial Distribution
R57405
ROCKET MEDICAL PLC
R57405
In Commercial Distribution
R57405
ROCKET MEDICAL PLC
Rocket KCH Fetal Bladder 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? |
---|---|---|---|---|
46234 | Closed-wound drainage kit, micro-drainage |
A collection of sterile devices designed to drain small, superficial abscesses and/or fluid collections. It will typically include an introducer needle, a guidewire, and a flexible, single-lumen, micro-drainage catheter with attached dilator that allows for atraumatic over-the-wire placement of the catheter. The initial puncture is made with the needle, the guidewire is advanced through the needle, which is then removed, and the catheter/dilator is advanced over the guidewire to obtain access to the site. The kit may have a wide range of surgical applications (e.g., general and plastic surgery). This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
H970001 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
99c35078-32c0-404f-b747-b05f91db8793
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 |
---|---|---|---|---|---|
05055270956460 | 30 | 05055270913678 | 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