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Na BIOD6DR252CT

by Sterilmed, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number10888551006460 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0555-2009 FDA Unclassified (pre-2012) initiated 8 Aug 2008

    SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Cardiac mapping catheter, percutaneous, reprocessed
Model / Ref / Catalog
BIOD6DR252CT
Primary DI / UDI-DI
10888551006460
510(k) Number
FDA Product Code
NLH
GMDN Term
Cardiac mapping catheter, percutaneous, reprocessed
Device Class
Class II
Regulation Number
870.1220
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide

Related devices

Cleared under the same submission (K043513)

Show all (12)

Other devices from Sterilmed, Inc.

See all devices from Sterilmed, Inc. →

Properties

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

Other properties (9)

  • Implantable: No
  • 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