AccessGUDID - DEVICE: Two-Cannula-System acc. Mancao (14048223004552)

GUDID

Device Identifier (DI) Information

Brand Name: Two-Cannula-System acc. Mancao
Version or Model: 0001151-20
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0001151-20
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223004552
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Two-Cannula-System acc. Mancao with stylet, 18G x 80mm (3 1/4")

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 [?]
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: d3edc02c-0cf7-4391-b619-bc4b783f8941
Public Version Date: March 15, 2022
Public Version Number: 4
DI Record Publish Date: August 30, 2016