DEVICE: EndoGI Specialized S-Path Delivery System (00860005738243)

Device Identifier (DI) Information

EndoGI Specialized S-Path Delivery System
Delivery System
In Commercial Distribution

ENDO GI MEDICAL LTD
00860005738243
GS1

1
532316194 *Terms of Use
The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
FGE Stents, Drains And Dilators For The Biliary Ducts
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K232596 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

17bf1b39-4e8f-47e6-80f5-ae54c11396c3
March 31, 2025
1
March 21, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+97246098600
omri@endogi-medical.com
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