DEVICE: Rocket (05055270913395)

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Device Identifier (DI) Information

Rocket
R55990
R55990
ROCKET MEDICAL PLC
05055270913395
GS1
1
Spinal Manometer Set - EA
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Device Characteristics

MR Safe
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
Cerebrospinal fluid manometer, mechanical A sterile device designed to directly measure the cerebrospinal fluid (CSF) pressure in a patient. It is a mechanical instrument that connects with a dedicated hollow needle inserted into the subarachnoid (intrathecal) space of the lumbar section of the spinal column; CSF pressure is typically displayed on a dial showing readings in, e.g., cmH2O or mmH2O. Connectors, tubing, and the spinal needle are typically included. The device is intended to be used to determine variations in CSF pressure for the purposes of diagnosing, assessing trauma, or to evaluate some other clinical condition (e.g., tumours). This is a single-use device.
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FDA Product Code

[?]
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

[?]
Storage and Handling
Storage Environment Temperature: between -5 and 30 Degrees Celsius
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage 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
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Clinically Relevant Size

[?]
Size Type Text
Length: 40.0 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

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05055270934789 40 05055270913395 In Commercial Distribution Carton
05055270956187 2 05055270934789 In Commercial Distribution Box
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
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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