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Palmaz Blue PB1250PPS

by Cordis Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10705032062022 UDI-DIDate31 Jul 2024ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Palmaz Blue
Generic Name
Bare-metal biliary stent
Model / Ref / Catalog
PB1250PPS
Primary DI / UDI-DI
10705032062022
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 (K040413)

Show all (12)

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

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

Other properties (7)

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