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Neptune® DNX-446

by Endochoice, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816849019277 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Neptune®
Generic Name
General-purpose endoscopic needle, single-use
Model / Reference
DNX-446
Primary DI / UDI-DI
00816849019277
FDA Product Code
FBK
GMDN Term
General-purpose endoscopic needle, single-use
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
Not in Commercial Distribution
Size
Needle Gauge — 25 Gauge

Other devices from Endochoice, Inc.

See all devices from Endochoice, Inc. →

Properties

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

Other properties (8)

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