AccessGUDID - DEVICE: HANAROSTENT® LowAxTM Colon/Rectum(NNN) (08806367080646)

GUDID

Device Identifier (DI) Information

Brand Name: HANAROSTENT® LowAxTM Colon/Rectum(NNN)
Version or Model: CNJF-20-120-230
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.I.Tech Co., Ltd.

Primary DI Number: 08806367080646
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 colon 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?
37847	Bare-metal colonic stent	A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the colon for the palliative treatment of colonic strictures caused by malignant neoplasms typically in the descending or sigmoid colon, or rectum. It is typically inserted and advanced to the site of implantation with a dedicated catheter, or other instrument, where it self-expands upon release. It is made of metal [e.g., stainless steel or metal alloy such as nickel-titanium alloy (Nitinol)] in a tubular mesh configuration, and is available in various sizes. It will typically be used to relieve large bowel obstruction prior to colectomy, or in patients having high operative risk and/or advanced disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQR	Stent, Colonic, Metallic, Expandable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183616	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: 2300 Millimeter
Stent Length: 120 Millimeter
Stent Diameter: 20 Millimeter

Device Record Status

Public Device Record Key: 97475f03-0b4c-4244-843a-b4841c44763f
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 18, 2019