AccessGUDID - DEVICE: Tuohy NRFit (14048223029852)

GUDID

Device Identifier (DI) Information

Brand Name: Tuohy NRFit
Version or Model: 1166-6M091
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1166-6M091
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223029852
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 25
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Tuohy NRFit

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?
58293	Epidural needle, non-threaded	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. 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 [?]
K160297	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37033c7f-fa4b-4945-a7a8-f9ba01c3bf0f
Public Version Date: March 17, 2025
Public Version Number: 5
DI Record Publish Date: December 15, 2016