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Co-Axial Introducer Needle MCXS2015TM

by Surgical Specialties México, S. de R.L. de C.V. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848782023738 UDI-DIDate20 Sep 2016ListedStatusListed 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  • Withdrawn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
Co-Axial Introducer Needle
Generic Name
Needle guide, single-use
Model / Reference
MCXS2015TM
Primary DI / UDI-DI
00848782023738
FDA Product Code
KNW
GMDN Term
Needle guide, single-use
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 19 Gauge

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No