AccessGUDID - DEVICE: HANAROSTENT® Trachea/Bronchium(CCC) (08806367080066)

GUDID

Device Identifier (DI) Information

Brand Name: HANAROSTENT® Trachea/Bronchium(CCC)
Version or Model: TCS-12-060-090
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.I.Tech Co., Ltd.

Primary DI Number: 08806367080066
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 tracheal 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?
43630	Polymer-metal tracheal/bronchial stent	A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic support structures), and may have a straight or branched configuration. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JCT	Prosthesis, Tracheal, Expandable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201342	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
Stent Diameter: 12 Millimeter
Stent Length: 60 Millimeter
Device Size Text, specify: 900 mm Delivery system

Device Record Status

Public Device Record Key: 7268b58f-84f2-4055-9a75-a7e2f340f3d3
Public Version Date: May 10, 2021
Public Version Number: 1
DI Record Publish Date: April 30, 2021