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Na Medial Large Grid Breast Biopsy Plate

by USA Instruments, Inc. United States GUDID

Product code LNH

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682138291 UDI-DIDate1 Dec 2017ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0516-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007
    • Terminated Z-0517-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007
    • Terminated Z-0518-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007

    The packaging used for the Breast Biopsy plate may exhibit small holes or tears

  • 2 recalls, same reason

    • Terminated Z-0519-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007
    • Terminated Z-0505-2007 FDA Unclassified (pre-2012) initiated 21 Nov 2006

    The packaging used for the Breast Biopsy plate may exhibit small holes or tears.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Radiological breast positioner, non-wearable
Model / Reference
MEDIAL LARGE GRID BREAST BIOPSY PLATE
Primary DI / UDI-DI
00840682138291
510(k) Number
FDA Product Code
LNH
GMDN Term
Radiological breast positioner, non-wearable
Device Class
Class II
Regulation Number
892.1000
Commercial Distribution
In Commercial Distribution

Related devices

Category: Radiological breast positioner, non-wearable

Cleared under the same submission (K041695)

Other devices from USA Instruments, Inc.

See all devices from USA Instruments, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Lot / Batch Number
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI a07be7f7-f16c-48bf-99d5-c4d244b0bf77 33 fields · synced 23 Oct 2026