AccessGUDID - DEVICE: Disposable Pre-calibrated Biopsy Needle (04048223099018)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Pre-calibrated Biopsy Needle
Version or Model: 42051-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 42051-01
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223099018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	No
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
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 257.0 Millimeter
Outer Diameter: 2.1 Millimeter

Device Record Status

Public Device Record Key: 0115a747-7d7b-4aa5-a809-5bcd4d23cea1
Public Version Date: February 06, 2025
Public Version Number: 1
DI Record Publish Date: January 29, 2025