AccessGUDID - DEVICE: Niti-S Biliary Speed D Stent (08809909414176)

GUDID

Device Identifier (DI) Information

Brand Name: Niti-S Biliary Speed D Stent
Version or Model: BDM1008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TAEWOONGMEDICAL.CO.,LTD

Primary DI Number: 08809909414176
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689484322 *Terms of Use

Device Description: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the 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 [?]
K223626	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 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Stent Diameter: 10 Millimeter
Stent Length: 80 Millimeter
Catheter Working Length: 180 Centimeter
Crossing Profile: 8.5 French

Device Record Status

Public Device Record Key: 1a751953-60a6-499b-8e53-db7645011899
Public Version Date: June 09, 2023
Public Version Number: 1
DI Record Publish Date: June 01, 2023