DEVICE: Rocket (05055270983824)

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Device Identifier (DI) Information

Rocket
R57034
R57034
ROCKET MEDICAL PLC
05055270983824
GS1
1
Rocket LX 17G CVS Needle
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Chorionic villus sampling needle set A collection of sterile devices intended for transabdominal chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorioinic villi (thread-like projections growing in the outermost extra-embryonic membrane) for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. The set typically includes a CVS needle with stylet, connectors, and tubing, and is introduced transcutaneously, usually under ultrasonographic guidance, into the womb. The suction for sampling is provided by the syringe. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal
Storage Environment Temperature: between -5 and 30 Degrees Celsius
Handling Environment Temperature: between -5 and 40 Degrees Celsius
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 1.473 Millimeter
Length: 17.0 Centimeter
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Device Status

In Commercial Distribution
January 17, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05055270942784 10 05055270983824 In Commercial Distribution Carton
05055270964182 8 05055270942784 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4401914196988
gudid@rocketmedical.com
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