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Sentinelle Vanguard Breast MRI Tabletop Coil

by Philips Ds North America LLC

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 Number00884838080966 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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
Sentinelle
Generic Name
MRI system coil, radio-frequency
Model / Ref / Catalog
Vanguard Breast MRI Tabletop Coil, 453530384632
Primary DI / UDI-DI
00884838080966
FDA Product Code
MOS
GMDN Term
MRI system coil, radio-frequency
Device Class
Class II
Regulation Number
892.1000
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: MRI system coil, radio-frequency

Other devices from Philips Ds North America LLC

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Properties

  • Serial Number

Other properties (13)

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