DEVICE: Rocket (05055270914019)
Device Identifier (DI) Information
Rocket
R57525-00-P1
In Commercial Distribution
R57525-00-P1
ROCKET MEDICAL PLC
R57525-00-P1
In Commercial Distribution
R57525-00-P1
ROCKET MEDICAL PLC
Rocket DIsposable Needle Guide
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? |
---|---|---|---|---|
45018 | Needle guide, single-use |
A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K032015 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: U/S transducer specific |
Lumen/Inner Diameter: 1.651 Millimeter |
Device Record Status
4403a0ab-8a50-4d02-b81e-d47917a84474
February 16, 2024
9
September 07, 2016
February 16, 2024
9
September 07, 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 |
---|---|---|---|---|---|
05055270935403 | 10 | 05055270914019 | In Commercial Distribution | ||
05055270956804 | 6 | 05055270935403 | 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