AccessGUDID - DEVICE: EndoTNeedle (00816207020174)

GUDID

Device Identifier (DI) Information

Brand Name: EndoTNeedle
Version or Model: ET1310
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ET1310
Company Name: ENDO-THERAPEUTICS, INC.

Primary DI Number: 00816207020174
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 825239189 *Terms of Use

Device Description: Endoscopic injection needle

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
FBK	Endoscopic Injection Needle, Gastroenterology-Urology

FDA Premarket Submission

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

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
Device Size Text, specify: Needle length 5 mm
Device Size Text, specify: Min Channel 2.8 mm
Outer Diameter: 2.3 Millimeter
Length: 230 Centimeter
Needle Gauge: 22 Gauge

Device Record Status

Public Device Record Key: c4052590-a7be-4e4e-ab8e-58a1a3dbd524
Public Version Date: September 16, 2022
Public Version Number: 5
DI Record Publish Date: September 22, 2016