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OPAL HDx™ M004OPAL11020

by Boston Scientific

Listed FDA GUDID listing, no authorization on record

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 Number00191506063214 UDI-DI Date20 Sep 2026ListedStatusListed GUDID: 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  • Withdrawn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
OPAL HDx™
Generic Name
Cardiac mapping system
Model / Ref / Catalog
M004OPAL11020
Primary DI / UDI-DI
00191506063214
FDA Product Code
DSA, DQK
GMDN Term
Cardiac mapping system
Device Class
Class II
Regulation Number
870.2900, 870.1425
GUDID distribution status
In Commercial Distribution

Other devices from Boston Scientific

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No