DEVICE: Rocket (05055270900333)

Device Identifier (DI) Information

Rocket
R57412
In Commercial Distribution
R57412
ROCKET MEDICAL PLC
05055270900333
GS1

1
544313588 *Terms of Use
Rocket URIGLOW Transilluminating Stents
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K943801 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 40.0 Centimeter
CLOSE

Device Record Status

62c57410-056b-4c4e-832c-96b55a04b1f2
July 06, 2018
3
September 02, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4401914196988
gudid@rocketmedical.com
CLOSE