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Palmaz Genesis PG595P

by Cordis Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705032057615 UDI-DI Date31 Jul 2024ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Palmaz Genesis
Generic Name
Bare-metal biliary stent
Model / Ref / Catalog
PG595P
Primary DI / UDI-DI
10705032057615
510(k) Number
FDA Product Code
FGE
GMDN Term
Bare-metal biliary stent
Device Class
Class II
Regulation Number
876.5010
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K012087)

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No