DEVICE: Quadra-Fuse Multi-Pronged Injection Needle (00857141005292)
Device Identifier (DI) Information
Quadra-Fuse Multi-Pronged Injection Needle
4518-20SS
In Commercial Distribution
4518-20SS
Rex Medical LLP
4518-20SS
In Commercial Distribution
4518-20SS
Rex Medical LLP
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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? |
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64279 | Multiple-pronged submucosal injection needle |
An instrument in the form of a needle with multiple sharp prongs intended to be used in conjunction with a syringe to administer a multiple-site injection into the submucosal layer of tissue, typically of anatomical structures with lumens. It includes a retractable proximal handle to manually deploy and position the needle in the target tissue, and is often used to inject substances (e.g., cell therapy preparations) into urethral tissues [e.g., mid-urethral tissue, external urethral sphincter], typically for treating female stress urinary incontinence (SUI). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAA | Needle, Aspiration And Injection, Disposable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1c34ec37-784c-479f-8991-913522d9f7dc
December 15, 2020
1
December 07, 2020
December 15, 2020
1
December 07, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
610-940-0665
sales@rexmedical.com
sales@rexmedical.com