AccessGUDID - DEVICE: Disposable Biopsy Needle (04048223028643)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Biopsy Needle
Version or Model: 41778B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 41778B
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223028643
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Disposable Biopsy Needle with Marker Plates; For Re-Order: 41779B (5 pcs of 41778B)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
38563	Brain biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable brain biopsy needle and other supplies used to perform a stereotaxic sampling of brain tissue. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument

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
No Device Sizes

Device Record Status

Public Device Record Key: 6e4c7e0d-35e7-471d-a5a0-815062cda257
Public Version Date: March 16, 2021
Public Version Number: 3
DI Record Publish Date: August 30, 2016