AccessGUDID - DEVICE: M-Biopsy Needle For Reusable Biopsy Instruments (15711055001547)

GUDID

Device Identifier (DI) Information

Brand Name: M-Biopsy Needle For Reusable Biopsy Instruments
Version or Model: N20220020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N20220020
Company Name: Mermaid Medical A/S

Primary DI Number: 15711055001547
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308951313 *Terms of Use

Device Description: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with a Pro-Mag™ Automatic Biopsy Instrument.

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":	Yes
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?
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWO	Needle, Biopsy, Cardiovascular

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
Special Storage Condition, Specify: Keep away from sunlight and keep dry

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 20 Gauge
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 65ba73b4-5abb-4e5a-8f83-f4237971f6c8
Public Version Date: October 04, 2023
Public Version Number: 2
DI Record Publish Date: August 05, 2019