DEVICE: Rocket (05055270914507)
Device Identifier (DI) Information
Rocket
R57625
In Commercial Distribution
R57625
ROCKET MEDICAL PLC
R57625
In Commercial Distribution
R57625
ROCKET MEDICAL PLC
Rocket DUO IUI Catheter 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? |
---|---|---|---|---|
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 [?] |
---|---|
K980061 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 18.0 Centimeter |
Device Record Status
624e0c62-f8ca-4bd3-afb1-8d171658378d
July 06, 2018
3
September 14, 2016
July 06, 2018
3
September 14, 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 |
---|---|---|---|---|---|
05055270935892 | 25 | 05055270914507 | In Commercial Distribution | ||
05055270957290 | 7 | 05055270935892 | 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