AccessGUDID - DEVICE: SonoLong Echo NanoLine (14048223019600)

GUDID

Device Identifier (DI) Information

Brand Name: SonoLong Echo NanoLine
Version or Model: 521185-31A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 521185-31A
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223019600
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: SonoLong Echo NanoLine SonoLong NanoLine cannula 19G x 100mm with facet tip and

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:	Yes
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?
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction kit

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: 1b96679d-a6a4-4db5-84ca-c73d312f5910
Public Version Date: March 17, 2025
Public Version Number: 5
DI Record Publish Date: September 07, 2016