AccessGUDID - DEVICE: HANAROSTENT® Benefit™ Biliary (NNN) (08806367093080)

GUDID

Device Identifier (DI) Information

Brand Name: HANAROSTENT® Benefit™ Biliary (NNN)
Version or Model: BNHS-08-120-180
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.I.Tech Co., Ltd.

Primary DI Number: 08806367093080
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688454359 *Terms of Use

Device Description: Un-covered self-expanding nitinol biliary 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?
43691	Bare-metal biliary stent	A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. 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
FGE	Stents, Drains And Dilators For The Biliary Ducts

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202973	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: 8 Millimeter
Stent Length: 120 Millimeter
Device Size Text, specify: 1800 mm Delivery system

Device Record Status

Public Device Record Key: b562cad0-cf2b-4c92-8f4f-350defbe8b47
Public Version Date: April 08, 2022
Public Version Number: 2
DI Record Publish Date: August 31, 2021