AccessGUDID - DEVICE: StimuLong Sono Tsui (14048223010096)

GUDID

Device Identifier (DI) Information

Brand Name: StimuLong Sono Tsui
Version or Model: 521156-35U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 521156-35U
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223010096
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2017
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: StimuLong Sono Tsui Tuohy Sono needle 18G x 90mm StimuLong Sono catheter 20G x 90cm with

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?
34842	Epidural anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia 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: b44ab620-c258-4013-b057-6d61e60ee77e
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: September 09, 2016