DEVICE: Rocket (05055270914828)

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Device Identifier (DI) Information

Rocket
R57802
R57802
ROCKET MEDICAL PLC
05055270914828
GS1
1
Rocket LLETZ Loop Large 22mm
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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
Electrocautery system electrode An active conductor (e.g., blade or loop) that is attached to an electrocautery system handpiece or other surgical instrument (e.g., an endoscopic device) which is heated via the electrical current from the generator and used during surgical intervention to burn or sear body tissue. It is made of an appropriate metal and is typically used to stop bleeding (cauterization of blood vessels) and to treat superficial skin lesions (e.g., removal of warts). This is a reusable 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 Temperature: between -5 and 40 Degrees Celsius
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
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 18.0 Millimeter
Outer Diameter: 22.0 Millimeter
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Device Status

In Commercial Distribution
September 08, 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
05055270957610 12 05055270936219 In Commercial Distribution
05055270936219 25 05055270914828 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)

[?]
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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