DEVICE: Rocket (05055270913616)
Device Identifier (DI) Information
Rocket
R57032
In Commercial Distribution
R57032
ROCKET MEDICAL PLC
R57032
In Commercial Distribution
R57032
ROCKET MEDICAL PLC
Rocket CVS Chorionic Sampling Needle
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? |
---|---|---|---|---|
56709 | Chorionic villus sampling needle |
A slender, sharply-pointed metal tube intended for transabdominal chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorionic villi for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. It is introduced transcutaneously into the uterus, possibly using a guide cannula and under ultrasonographic guidance, and may include connectors, tubing and aspiration 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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling 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 |
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 1.473 Millimeter |
Length: 17.0 Centimeter |
Device Record Status
d0c2617a-5262-49a7-9a7a-61141e41605b
March 05, 2020
3
January 17, 2017
March 05, 2020
3
January 17, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05055270956408 | 100 | 05055270913616 | In Commercial Distribution | Box |
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