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BEXCORE Breast Biopsy Needle BXC135

by Medical Park Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800025901854 UDI-DIDate1 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
BEXCORE Breast Biopsy Needle
Generic Name
Side-notch biopsy gun handpiece/needle
Model / Reference
BXC135
Primary DI / UDI-DI
08800025901854
FDA Product Code
FCG
GMDN Term
Side-notch biopsy gun handpiece/needle
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No