DEVICE: Rocket (05055270913623)

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Device Identifier (DI) Information

Rocket
R57040
R57040
ROCKET MEDICAL PLC
05055270913623
GS1
1
Rocket Pudendal Block Needle
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Pudendal anaesthesia kit A collection of sterile devices designed to deliver an analgesic or anaesthetic agent to the external genitalia of humans. It typically consists of a procedural needle, syringe, catheter, and a filter. It is typically used during labour, delivery, or both. 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 Humidity: between 1 and 70 Percent (%) Relative Humidity
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between -5 and 30 Degrees Celsius
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal
Handling Environment Temperature: between -5 and 40 Degrees Celsius
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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
February 03, 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
05055270956415 4 05055270935014 In Commercial Distribution Box
05055270935014 20 05055270913623 In Commercial Distribution Carton
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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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