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HydroMark CA000407003

by Devicor Medical Products, Inc.

HydroMark CA000407003 (4010-02-15-T1) is a Class II device made by Devicor Medical Products, Inc., listed in FDA GUDID since 13 Dec 2016 (UDI-DI 00841911100096), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841911100096 UDI-DI Date13 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
CA000407003, 4010-02-15-T1
Primary DI / UDI-DI
00841911100096
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

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Other devices filed under Radiological image marker, implantable.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)