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Percutaneous Micro-Introducer Kit 497813

by Argon Medical Devices, Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886333215034 UDI-DI Date9 Sep 2016ListedStatusListed 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  • Withdrawn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
Percutaneous Micro-Introducer Kit
Generic Name
Magnetocardiography system
Model / Ref / Catalog
497813
Primary DI / UDI-DI
00886333215034
FDA Product Code
OFL
GMDN Term
Magnetocardiography system
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No