AccessGUDID - DEVICE: S-Path Pre-loaded RX Biliary Stent System (80mm) (00860005738229)

GUDID

Device Identifier (DI) Information

Brand Name: S-Path Pre-loaded RX Biliary Stent System (80mm)
Version or Model: Single-Stent (80mm)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDO GI MEDICAL LTD

Primary DI Number: 00860005738229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532316194 *Terms of Use

Device Description: The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 80 mm stent preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.

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?
43764	Polymeric biliary stent, non-bioabsorbable	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). 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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Stent Length: 80 Millimeter

Device Record Status

Public Device Record Key: 76245121-9642-44c3-ae54-fa48f3bc5793
Public Version Date: September 05, 2023
Public Version Number: 1
DI Record Publish Date: August 28, 2023