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HydroMARK 4010-01-08-T1

by Devicor Medical Products, Inc. 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841911103325 UDI-DI Date2 Oct 2025ListedStatusListed 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  • Withdrawn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
HydroMARK
Generic Name
Radiological image marker, implantable
Model / Ref / Catalog
4010-01-08-T1, CA000960002
Primary DI / UDI-DI
00841911103325
FDA Product Code
NEU
GMDN Term
Radiological image marker, implantable
Device Class
Class II
Regulation Number
878.4300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Devicor Medical Products, Inc.

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Properties

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

Other properties (8)

  • 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