AccessGUDID - DEVICE: Single Use Surgical Professional (05055299106211)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Surgical Professional
Version or Model: S443
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S443
Company Name: EAKIN SURGICAL LIMITED

Primary DI Number: 05055299106211
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 239505063 *Terms of Use

Device Description: Drainage Cannula 6fg 9cm

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?
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return	A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAA	Needle, Aspiration And Injection, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Catheter Gauge: 6 French
Length: 9 Centimeter

Device Record Status

Public Device Record Key: 41dbd341-2378-46e4-a87e-06ba77b0e4b4
Public Version Date: June 19, 2024
Public Version Number: 6
DI Record Publish Date: August 19, 2016