DEVICE: Rocket (05055270973511)

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Device Identifier (DI) Information

Rocket
R57424-00-ST
R57424-00-ST
ROCKET MEDICAL PLC
05055270973511
GS1
1
Rocket 7Fg HSG Sonohystogram Catheter
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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
Intrauterine imaging medium catheter A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, 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
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
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
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
Length: 30.0 Centimeter
Catheter Gauge: 5.0 French
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Device Status

In Commercial Distribution
September 22, 2016

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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
05055270973528 10 05055270973511 In Commercial Distribution
05055270973535 20 05055270973528 In Commercial Distribution
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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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