AccessGUDID - DEVICE: VACU-CUT® (00801741083907)

GUDID

Device Identifier (DI) Information

Brand Name: VACU-CUT®
Version or Model: 17640070
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 17640070
Company Name: Angiomed GmbH & Co. Medizintechnik KG

Primary DI Number: 00801741083907
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 320047483 *Terms of Use

Device Description: VACU-CUT® Disposable Aspiration Biopsy Needle 18g x 150mm

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
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 150 Millimeter

Device Record Status

Public Device Record Key: fb6d7683-953f-42af-a378-b60bec5f9993
Public Version Date: April 17, 2024
Public Version Number: 4
DI Record Publish Date: September 06, 2016