AccessGUDID - DEVICE: HANAROSTENT® Esophagus Asymmetric (CCC) (08806367044747)

GUDID

Device Identifier (DI) Information

Brand Name: HANAROSTENT® Esophagus Asymmetric (CCC)
Version or Model: ECN24120-Z070
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.I.Tech Co., Ltd.

Primary DI Number: 08806367044747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688454359 *Terms of Use

Device Description: Full Covered metallic esophagus stent

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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 [?]
K213251	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 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 700 mm Delivery system
Stent Diameter: 24 Millimeter
Stent Length: 120 Millimeter

Device Record Status

Public Device Record Key: 0f8089eb-3c1b-47aa-9eca-7a00ee11ee6e
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: December 31, 2021