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PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System

FDA UDI

Class II (US FDA UDI)

by Cordis Corp.

Identity

Trade Name
PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System FDA UDI
Generic Name
Bare-metal biliary stent FDA UDI
Model / Reference
PG2960BSX FDA UDI

Identifiers

Catalog Number
PG2960BSX FDA UDI
Primary DI / UDI-DI
20705032039588 FDA UDI
510(k) Number
K021345 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Bare-metal biliary stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System by Cordis Corp. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K021345 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cordis Corp.

Sources (1)

  • FDA UDI 438a1166-d07f-4a51-a90b-b089b0ab94e1 36 fields · synced Jun 8, 2026