AccessGUDID - DEVICE: Disposable Sclerotherapy Needle (00813353010233)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Sclerotherapy Needle
Version or Model: 2010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Telemed Systems

Primary DI Number: 00813353010233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017939239 *Terms of Use

Device Description: Sure-Stop Sclerotherapy Needle 21GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
64114	Sclerotherapy endoscopic needle, single-use	A device intended to be used with an appropriate endoscope to inject a pharmaceutical into mucosa or a vessel during sclerotherapy (a treatment that involves injecting varicose veins with a sclerosing fluid). It is in the form of a flexible tube with a needle at the distal end and a syringe connector at the proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBK	Endoscopic Injection Needle, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K901437	000

Device Exempt from Premarket Submission: No 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: d4cfcdd6-f92a-47e2-a4a0-234c631d5a70
Public Version Date: September 01, 2023
Public Version Number: 1
DI Record Publish Date: August 24, 2023