DEVICE: Rocket (05055270965875)
Device Identifier (DI) Information
Rocket
R51400-00-PP
In Commercial Distribution
R51400-00-PP
ROCKET MEDICAL PLC
R51400-00-PP
In Commercial Distribution
R51400-00-PP
ROCKET MEDICAL PLC
Rocket IPC Mini Dressing Pack & Bottle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11266 | Fixed-diameter cervical dilator, reusable |
A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123033 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5fdb4286-4924-46c3-b45e-0bf30f781a53
July 06, 2018
3
September 08, 2016
July 06, 2018
3
September 08, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05055270965899 | 5 | 05055270965875 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401914196988
gudid@rocketmedical.com
gudid@rocketmedical.com