DEVICE: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System (20705032039632)
Device Identifier (DI) Information
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System
PG2970BPS
In Commercial Distribution
PG2970BPS
CORDIS CORPORATION
PG2970BPS
In Commercial Distribution
PG2970BPS
CORDIS CORPORATION
No description.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
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 | CATHETER, BILIARY, DIAGNOSTIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K033394 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dark, dry place. |
Special Storage Condition, Specify: Do not use open or damaged packages |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fe32a5c7-27e8-4c3f-a744-22fb49f9ecfa
August 10, 2022
7
August 28, 2015
August 10, 2022
7
August 28, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined