DEVICE: Rocket (05055270912169)
Device Identifier (DI) Information
Rocket
R50000
In Commercial Distribution
R50000
ROCKET MEDICAL PLC
R50000
In Commercial Distribution
R50000
ROCKET MEDICAL PLC
Rocket Suture ScIssors 11cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
13502 | Suture scissors |
A hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically metallic and is available in various designs and sizes; the blades may have different shapes, e.g., they can be curved or straight with a hook-like tip to capture the suture/ligature as it is cut. It is not a dedicated ophthalmic device. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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Length: 11.0 Centimeter |
Device Record Status
77a886b3-7853-42d7-b24b-7cb7e255e3ed
June 26, 2018
3
January 17, 2017
June 26, 2018
3
January 17, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05055270954954 | 12 | 05055270933553 | In Commercial Distribution | Box | |
05055270933553 | 25 | 05055270912169 | In Commercial Distribution | Carton |
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