AccessGUDID - DEVICE: Z-Stent (00827002248717)

GUDID

Device Identifier (DI) Information

Brand Name: Z-Stent
Version or Model: G24871
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EZS-25-12-70-AR
Company Name: COOK INCORPORATED

Primary DI Number: 00827002248717
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 079720472 *Terms of Use

Device Description: Z-Stent Esophageal with Dua Anti-Reflux Valve

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):	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?
61751	Polymer-metal oesophageal stent	A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ESW	PROSTHESIS, ESOPHAGEAL

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dark, dry, cool place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c36c7cdb-310d-4459-8932-450ce3a28233
Public Version Date: July 14, 2023
Public Version Number: 3
DI Record Publish Date: November 03, 2015