AccessGUDID - DEVICE: Westcott Biopsy Needle (00886333003129)

GUDID

Device Identifier (DI) Information

Brand Name: Westcott Biopsy Needle
Version or Model: MWN2208US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MWN2208US
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333003129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Westcott Biopsy Needle with Echogenic Tip 22ga x 20cm

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?
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980122	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 and away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 22ga x 20cm

Device Record Status

Public Device Record Key: 3135bd70-98a3-4385-a99f-a65aea88d657
Public Version Date: May 11, 2026
Public Version Number: 3
DI Record Publish Date: October 07, 2021