AccessGUDID - DEVICE: SONOTAP II (04048223116296)

GUDID

Device Identifier (DI) Information

Brand Name: SONOTAP II
Version or Model: 1285-3F150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1285-3F150
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223116296
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 04048223057933

Device Description: 1285-3F150

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 [?]
K113207	000
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 10 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69b50ddf-c385-4eba-97fb-11e88efc1505
Public Version Date: June 30, 2025
Public Version Number: 4
DI Record Publish Date: July 07, 2021