AccessGUDID - DEVICE: HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) (08806367076632)

GUDID

Device Identifier (DI) Information

Brand Name: HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)
Version or Model: DNJF-22-060-140
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.I.Tech Co., Ltd.

Primary DI Number: 08806367076632
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 Duodenum stent

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
32640	Bare-metal duodenal stent	A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded 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
MUM	Stent, Metallic, Expandable, Duodenal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180180	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
Length: 1400 Millimeter
Stent Length: 60 Millimeter
Stent Diameter: 22 Millimeter

Device Record Status

Public Device Record Key: b4113280-0b0b-4af6-ac4f-bad35393f8bc
Public Version Date: December 21, 2018
Public Version Number: 1
DI Record Publish Date: November 20, 2018