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
00857141005292
GS1

1
079535216 *Terms of Use
No description.
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GAA Needle, Aspiration And Injection, Disposable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

1c34ec37-784c-479f-8991-913522d9f7dc
December 15, 2020
1
December 07, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
610-940-0665
sales@rexmedical.com
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