AccessGUDID - DEVICE: Coaxial SABD Biopsy Device (00886333218400)

GUDID

Device Identifier (DI) Information

Brand Name: Coaxial SABD Biopsy Device
Version or Model: CS-2015-15-T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CS-2015-15-T
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333218400
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Coaxial SABD Biopsy Device

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?
22726	End-cut biopsy gun handpiece/needle	A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCG	Biopsy Needle

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 19ga (1.1mm) x 10.6cm Introducer
Device Size Text, specify: 20G (0.9mm) x 15cm SABD

Device Record Status

Public Device Record Key: bc5b9717-cae5-4c4e-b1ed-20d0f5a9dfaf
Public Version Date: February 01, 2024
Public Version Number: 4
DI Record Publish Date: September 17, 2016