DEVICE: Rocket (05055270914651)
Device Identifier (DI) Information
Rocket
R57636-00-23
In Commercial Distribution
R57636-00-23
ROCKET MEDICAL PLC
R57636-00-23
In Commercial Distribution
R57636-00-23
ROCKET MEDICAL PLC
Rocket Bulb Tip Trial Transfer Set 23cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
41438 | Assisted reproduction catheter set |
A collection of sterile devices used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. 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 [?] |
---|---|
K994327 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 23.0 Centimeter |
Device Record Status
2320a95b-b8aa-49ae-8b85-6740a1299485
July 06, 2018
3
September 08, 2016
July 06, 2018
3
September 08, 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 |
---|---|---|---|---|---|
05055270936042 | 10 | 05055270914651 | In Commercial Distribution | ||
05055270957443 | 10 | 05055270936042 | 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