DEVICE: Rocket (05055270914057)
Device Identifier (DI) Information
Rocket
R57545
In Commercial Distribution
R57545
ROCKET MEDICAL PLC
R57545
In Commercial Distribution
R57545
ROCKET MEDICAL PLC
Rocket Embryon Embryo Transfer Set 18cm
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
47341 | Intrauterine curette, suction |
A sterile, tubular, semi-rigid, hand-held device used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device typically has a rounded blunt nose and an opening(s) with a blunt scraping edge(s) at the distal end. It is connected at the proximal end to tubing and a suction source, typically an abortion suction system, which provides regulated suction. Also known as a pregnancy termination catheter, it is typically made of plastic and is available in various shapes and sizes. 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 [?] |
---|---|
K994327 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 18.0 Centimeter |
Device Record Status
9b78d0a0-508b-498a-9042-a57a79ebd54e
July 06, 2018
3
September 17, 2016
July 06, 2018
3
September 17, 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 |
---|---|---|---|---|---|
05055270956842 | 8 | 05055270935441 | In Commercial Distribution | ||
05055270935441 | 10 | 05055270914057 | 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