AccessGUDID - DEVICE: SonoTAP II NRFit (14048223033835)

GUDID

Device Identifier (DI) Information

Brand Name: SonoTAP II NRFit
Version or Model: 1265-3F110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1265-3F110
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223033835
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: SonoTAP II NRFit 21G x 110mm with bevel tip and Cornerstone Reflectors

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:	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 [?]
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: c90a1e0d-833f-4231-bfc0-8e6964f7a963
Public Version Date: March 17, 2025
Public Version Number: 4
DI Record Publish Date: December 05, 2017