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Breast BI 7 MR Coil Set 3T 04

by NORAS MRI products GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number04251269205491 UDI-DI Date31 Jan 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Breast BI 7 MR Coil Set 3T
Generic Name
MRI system coil, radio-frequency
Model / Ref / Catalog
04, 118890
Primary DI / UDI-DI
04251269205491
510(k) Number
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

Cleared under the same submission (K162651)

Show all (12)

Other devices from Moras Mri Products GmbH

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Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (10)

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