DEVICE: Rocket (05055270900333)

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Device Identifier (DI) Information

Rocket
R57412
R57412
ROCKET MEDICAL PLC
05055270900333
GS1
1
Rocket URIGLOW Transilluminating Stents
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Device Characteristics

MR Safe
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
Fibreoptic ureteral catheter, single-use A sterile, flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for illumination to enable the path of the ureter to be seen. It also includes a plug for connection to a fibreoptic light source and a port for irrigation at its proximal end. The catheter is used to aid in dissection and placement of sutures during bladder surgery and for transillumination of the ureters during laparoscopic or open lower abdominal/pelvic surgery. 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
Handling Environment Temperature: between -5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal
Storage 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
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Length: 40.0 Centimeter
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Device Status

In Commercial Distribution
September 02, 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
05055270943125 40 05055270900333 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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