AccessGUDID - DEVICE: SONOBLOCK (04048223051689)

GUDID

Device Identifier (DI) Information

Brand Name: SONOBLOCK
Version or Model: 001281-95
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001281-95
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223051689
Issuing Agency: GS1
Commercial Distribution End Date: December 28, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 14048223037109

Device Description: 001281-95

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?
61547	Peripheral nerve-block sharp needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device.	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 [?]
K111374	000
K241954	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 Humidity: between 10 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a691124-4e63-4f78-a7a2-7fd9aec60724
Public Version Date: June 30, 2025
Public Version Number: 6
DI Record Publish Date: April 02, 2021