AccessGUDID - DEVICE: SonoTAP II NRFit (04048223077962)

GUDID

Device Identifier (DI) Information

Brand Name: SonoTAP II NRFit
Version or Model: 1265-3Y050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1265-3Y050
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223077962
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: SonoTAP II NRFit 24G x 50mm with bevel tip and Cornerstone Reflectors

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?
61548	Rapid-contact laboratory freezer	A mains electricity (AC-powered) appliance intended to be used to rapidly freeze bags containing plasma or other biological specimens to a core temperature of -30° Celsius (-22° Fahrenheit). It typically consists of a single or multiple shelves with adjustable contact plates, between which the bags are placed for freezing. It is not intended for storage; frozen bags are subsequently transferred to an appropriate storage freezer. It has sensors, controls, and monitors to display freezing progress (time/temperature graphs). It may include associated software for documentation of data and tracing of the bags.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243525	000

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 20 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 24.0 Gauge
Length: 50.0 Millimeter

Device Record Status

Public Device Record Key: 7f2afc4a-b935-4692-b33f-4cb6558f21a1
Public Version Date: July 07, 2025
Public Version Number: 1
DI Record Publish Date: June 27, 2025