AccessGUDID - DEVICE: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035 Delivery System (10705032039352)

GUDID

Device Identifier (DI) Information

Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035 Delivery System
Version or Model: PG2510BPX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PG2510BPX
Company Name: Cordis US Corp.

Primary DI Number: 10705032039352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118274128 *Terms of Use

Device Description: SDS Genesis 10x25mm 135 cm pro

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 [?]
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
No Device Sizes

Device Record Status

Public Device Record Key: 1d44434a-066b-4891-a18d-29fa245137da
Public Version Date: September 05, 2025
Public Version Number: 2
DI Record Publish Date: February 23, 2024