AccessGUDID - DEVICE: TUOHY (04048223115923)

GUDID

Device Identifier (DI) Information

Brand Name: TUOHY
Version or Model: 1166-6O081
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1166-6O081
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223115923
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2025
Device Count: 25
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 04048223056042

Device Description: Tuohy-Kanüle

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?
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
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
Outer Diameter: 1.6 Millimeter
Length: 80.0 Millimeter

Device Record Status

Public Device Record Key: 8b88d7bc-6a34-4729-aabd-827dcb93682e
Public Version Date: June 17, 2025
Public Version Number: 4
DI Record Publish Date: July 07, 2021