AccessGUDID - DEVICE: NA (06959664932186)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: AG-5311-2420-2206M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hangzhou AGS MedTech Co., Ltd.

Primary DI Number: 06959664932186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 542984702 *Terms of Use

Device Description: the Catheter OD is 2.4mm, working length is 2000mm, model of needle is 22, needle extension length is 6 mm, the headend type is metal cap

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?
38825	General-purpose endoscopic needle, single-use	A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. 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 [?]
K190032	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
Device Size Text, specify: model of needle, needle extension length

Device Record Status

Public Device Record Key: 91bbf0e0-1410-48e3-8a06-51b26c9aad1e
Public Version Date: December 14, 2021
Public Version Number: 1
DI Record Publish Date: December 06, 2021