AccessGUDID - DEVICE: CHIBA SONO (04048223067758)

GUDID

Device Identifier (DI) Information

Brand Name: CHIBA SONO
Version or Model: 530S070100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 530S070100
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223067758
Issuing Agency: GS1
Commercial Distribution End Date: May 25, 2024
Device Count: 25
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 14048223020392

Device Description: 530S070100

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):	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?
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCG	Biopsy needle

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 Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 094cb8ac-2d13-4c95-8549-ebabd9e962d1
Public Version Date: May 27, 2024
Public Version Number: 3
DI Record Publish Date: April 02, 2021