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Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on GE System R11657484

by Sterilmed, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number10888551045742 UDI-DI Date6 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on GE System
Generic Name
Intracardiac ultrasound imaging catheter, steerable, reprocessed
Model / Ref / Catalog
R11657484
Primary DI / UDI-DI
10888551045742
510(k) Number
FDA Product Code
OWQ
GMDN Term
Intracardiac ultrasound imaging catheter, steerable, reprocessed
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K254149)

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