AccessGUDID - DEVICE: BIOPTY-CUT (00801741084157)

GUDID

Device Identifier (DI) Information

Brand Name: BIOPTY-CUT
Version or Model: 451816
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 451816
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 00801741084157
Issuing Agency: GS1
Commercial Distribution End Date: March 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: BIOPTY-CUT® Disposable Core Biopsy Needle with Spacer, 18g x 16cm

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?
64328	Side-notch 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 small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is a percutaneously-inserted needle with a side-notch cutter at the distal end which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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
KNW	INSTRUMENT, BIOPSY

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
Needle Gauge: 18 Gauge
Length: 16 Centimeter

Device Record Status

Public Device Record Key: cda8aea7-5fc8-4f1d-a0e2-61c151e888ed
Public Version Date: August 28, 2024
Public Version Number: 5
DI Record Publish Date: September 13, 2016