DEVICE: Rocket (05055270914224)

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Device Identifier (DI) Information

Rocket
R57596
R57596
ROCKET MEDICAL PLC
05055270914224
GS1
1
Rocket Microsyringe for Embryo Transfer
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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
X-ray contrast medium, inhaled gas A gas formulation that is intended to be inhaled by the patient in order to temporarily enable or enhance the ability to differentially visualize targeted body structures on images generated by various diagnostic x-ray systems, e.g., computed tomography (CT) or fluoroscopy. It is used in x-ray imaging applications and intended to increase the ability to differentiate between normal and pathological conditions when analysing or interpreting medical images and information generated using a diagnostic x-ray system. After application, this device cannot be reused.
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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
Handling Environment Temperature: between -5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between -5 and 30 Degrees Celsius
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 0.3 Milliliter
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Device Status

In Commercial Distribution
September 17, 2016

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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
05055270935618 50 05055270914224 In Commercial Distribution
05055270957016 2 05055270935618 In Commercial Distribution
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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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