AccessGUDID - DEVICE: Articulator (00724995180874)

GUDID

Device Identifier (DI) Information

Brand Name: Articulator
Version or Model: 00711810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711810
Company Name: US Endoscopy

Primary DI Number: 00724995180874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 00816765011881

Device Description: The Articulator injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.

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):	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
FCG	Biopsy needle
FBK	endoscopic injection needle, gastroenterology-urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232826	000
K971842	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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 25 Gauge
Outer Diameter: 2.5 Millimeter
Length: 230 Centimeter

Device Record Status

Public Device Record Key: 34b86d2a-f7cf-45b7-9f77-1f5a4806368d
Public Version Date: March 19, 2024
Public Version Number: 3
DI Record Publish Date: April 01, 2020