AccessGUDID - DEVICE: Quadra-Fuse Multi-Pronged Injection Needle (00857141005285)

GUDID

Device Identifier (DI) Information

Brand Name: Quadra-Fuse Multi-Pronged Injection Needle
Version or Model: 4218-20SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4218-20SS
Company Name: Rex Medical LLP

Primary DI Number: 00857141005285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079535216 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
GAA	Needle, Aspiration And Injection, Disposable

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6dfb9f8c-2568-4295-b2e9-01ca5f77d627
Public Version Date: December 15, 2020
Public Version Number: 1
DI Record Publish Date: December 07, 2020