AccessGUDID - DEVICE: WallFlex™ Biliary (00191506026165)

GUDID

Device Identifier (DI) Information

Brand Name: WallFlex™ Biliary
Version or Model: M00547420
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M00547420
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506026165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: RX Partially Covered Stent System

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?
43566	Polymer-metal biliary stent, non-bioabsorbable	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 a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. 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
FGE	Stents, drains and dilators for the biliary ducts

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Stent Diameter: 8 Millimeter
Stent Length: 100 Millimeter

Device Record Status

Public Device Record Key: da1b2470-7c55-407c-8283-7f5d6c6289d9
Public Version Date: July 14, 2023
Public Version Number: 1
DI Record Publish Date: July 06, 2023