AccessGUDID - DEVICE: 17ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point (00815686020224)

GUDID

Device Identifier (DI) Information

Brand Name: 17ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point
Version or Model: INS-5017
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: INS-5017
Company Name: VERAN MEDICAL TECHNOLOGIES INC.

Primary DI Number: 00815686020224
Issuing Agency: GS1
Commercial Distribution End Date: June 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 181714804 *Terms of Use

Device Description: No description.

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?
64327	End-cut biopsy gun needle	An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) 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 is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093146	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
No Device Sizes

Device Record Status

Public Device Record Key: 7d17a1fc-a8e7-41db-91c8-88fec0054bf4
Public Version Date: February 13, 2023
Public Version Number: 4
DI Record Publish Date: August 31, 2016